A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)

• Sponsor: Centocor, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00046228
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 2,461
• Locations: 235
• Arms: 3
• Duration (Months): 65
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: abciximab placebo; reteplase placebo, abciximab, abciximab; Drug: Abciximab; reteplase; abciximab placebo; abciximab; Drug: abciximab; reteplase placebo; abciximab placebo; abciximab; Drug: abciximab placebo; reteplase placebo, abciximab, abciximab; Drug: abciximab; reteplase placebo; abciximab placebo; abciximab; Drug: Abciximab; reteplase; abciximab placebo; abciximab	Phase 3

Detailed Description

The purpose of this medical research study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention. This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death, and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment.

Patients will receive either abciximab and reteplease or abciximab alone. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2461 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.
• Study Start Date: Aug 1, 2002
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 Abciximab; reteplase; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	Drug: abciximab placebo; reteplase placebo, abciximab, abciximab; placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h; Drug: Abciximab; reteplase; abciximab placebo; abciximab; 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Experimental: 002 abciximab; reteplase placebo; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	Drug: Abciximab; reteplase; abciximab placebo; abciximab; 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h; Drug: abciximab; reteplase placebo; abciximab placebo; abciximab; 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Experimental: 003 abciximab placebo; reteplase placebo, abciximab, abciximab placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	Drug: abciximab; reteplase placebo; abciximab placebo; abciximab; 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h; Drug: abciximab placebo; reteplase placebo, abciximab, abciximab; placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h

Outcome Measures

Primary Outcome Measures

1. The Composite of All-Cause Mortality or Complications of MI at 90 Days. [90 days]

   Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).

Secondary Outcome Measures

1. Complications of MI as Defined in the Primary Outcome Measure Through 90 Days [90 Days]

   The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.

2. All-Cause Mortality Through 90 Days [90 days]

   All cause mortality occurred through 90 days from randomization.

3. Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization [60 to 90 minutes]

4. All-Cause Mortality Through 1 Year [1 year]

   All-cause mortality through 1 year from randomization.

Other Outcome Measures

1. Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 [Discharge/Day 7]

   All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).

2. Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 [Discharge/Day 7]

   Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.

3. Subjects With Severe Thrombocytopenia Through Discharge/Day 7 [Discharge/Day 7]

   Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.

4. Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 [Discharge/Day 7]

5. Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 [Discharge/Day 7]

   Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of A heart attack not eliminated with nitrates and onset within 6 hours of randomization,and confirmation by Electrocardiogram

Exclusion Criteria:

• Low risk clinical presentation

• patients who will not be undergoing a catherization within 4 hours of the qualifying Electrocardiogram

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Covina	California	United States
3		Modesto	California	United States
4		Newark	Delaware	United States
5		Washington	District of Columbia	United States
6		Clearwater	Florida	United States
7		Jacksonville	Florida	United States
8		Miami	Florida	United States
9		Saint Petersburg	Florida	United States
10		St Petersburg	Florida	United States
11		Tallahassee	Florida	United States
12		Weston	Florida	United States
13		Harvey	Illinois	United States
14		Rock Island	Illinois	United States
15		Lexington	Kentucky	United States
16		Louisville	Kentucky	United States
17		New Orleans	Louisiana	United States
18		Lewiston	Maine	United States
19		Worcester	Massachusetts	United States
20		Ann Arbor	Michigan	United States
21		Pontiac	Michigan	United States
22		Saint Louis	Missouri	United States
23		Brooklyn	New York	United States
24		Flushing	New York	United States
25		Mineola	New York	United States
26		New York	New York	United States
27		Raleigh	North Carolina	United States
28		Winston Salem	North Carolina	United States
29		Akron	Ohio	United States
30		Cleveland	Ohio	United States
31		Dayton	Ohio	United States
32		Westlake	Ohio	United States
33		Oklahoma City	Oklahoma	United States
34		Tulsa	Oklahoma	United States
35		Hershey	Pennsylvania	United States
36		Philadelphia	Pennsylvania	United States
37		Sayre	Pennsylvania	United States
38		Sellersville	Pennsylvania	United States
39		Upland	Pennsylvania	United States
40		Wormleysburg	Pennsylvania	United States
41		York	Pennsylvania	United States
42		Pawtucket	Rhode Island	United States
43		Providence	Rhode Island	United States
44		Spartanburg	South Carolina	United States
45		Bristol	Tennessee	United States
46		Kingsport	Tennessee	United States
47		Amarillo	Texas	United States
48		Galveston	Texas	United States
49		Houston	Texas	United States
50		Lubbock	Texas	United States
51		Bremerton	Washington	United States
52		Marshfield	Wisconsin	United States
53		Waukesha	Wisconsin	United States
54		Adrogue		Argentina
55		Buenos Aires		Argentina
56		Corrientes		Argentina
57		Merlo		Argentina
58		Rosario		Argentina
59		San Martin		Argentina
60		Bruck An Der Mur		Austria
61		Deutschlandsberg		Austria
62		Innsbruck		Austria
63		Linz		Austria
64		Wien		Austria
65		Antwerpen		Belgium
66		Bonheiden		Belgium
67		Eeklo		Belgium
68		Gent		Belgium
69		Herentals		Belgium
70		Mechelen		Belgium
71		Reet		Belgium
72		Turnhout		Belgium
73		Waregem		Belgium
74		Westmalle		Belgium
75		Dimitrovgrad		Bulgaria
76		Haskovo		Bulgaria
77		Plovdiv		Bulgaria
78		Sofia		Bulgaria
79		Edmonton	Alberta	Canada
80		Montreal	Quebec	Canada
81		Repentigny	Quebec	Canada
82		Benesov U Prahy		Czech Republic
83		Bilovec N/A		Czech Republic
84		Boskovice		Czech Republic
85		Brno		Czech Republic
86		Bruntál 1		Czech Republic
87		Bruntál		Czech Republic
88		Caslav N/A		Czech Republic
89		Ceske Budejovice		Czech Republic
90		Cesky Krumlov N/A		Czech Republic
91		Havíøov 1		Czech Republic
92		Hodonín 1		Czech Republic
93		Hradec Kralove		Czech Republic
94		Hranice 1		Czech Republic
95		Jeseník 1		Czech Republic
96		Jicin N/A		Czech Republic
97		Jihlava N/A		Czech Republic
98		Karniva-Ray N/A		Czech Republic
99		Kyjov		Czech Republic
100		Most N/A		Czech Republic
101		Novy Jicin N/A		Czech Republic
102		Odry		Czech Republic
103		Olomouc		Czech Republic
104		Ostrava		Czech Republic
105		Pisek N/A		Czech Republic
106		Poruba		Czech Republic
107		Praha 10 N/A		Czech Republic
108		Praha 9		Czech Republic
109		Prerov N/A		Czech Republic
110		Prostejov N/A		Czech Republic
111		Strakonice N/A		Czech Republic
112		Sumperk N/A		Czech Republic
113		Svitavy N/A		Czech Republic
114		Tabor N/A		Czech Republic
115		Teplice		Czech Republic
116		Trutnov N/A		Czech Republic
117		Tøebíè 1		Czech Republic
118		Tøinec 1		Czech Republic
119		Usti Nad Orlici N/A		Czech Republic
120		Valasske Mezirici N/A		Czech Republic
121		Vyskov N/A		Czech Republic
122		Znojmo N/A		Czech Republic
123		Ústí Nad Labem 11		Czech Republic
124		Esbjerg N/A		Denmark
125		Frederikshavn N/A		Denmark
126		Hjÿrring N/A		Denmark
127		Horsens N/A		Denmark
128		Kÿbenhavn Nv N/A		Denmark
129		Kÿbenhavn Sud N/A		Denmark
130		Kÿbenhavn Ÿ		Denmark
131		Odense N/A		Denmark
132		Randers		Denmark
133		Silkeborg		Denmark
134		Viborg N/A		Denmark
135		Ÿlborg		Denmark
136		Ÿrhus N		Denmark
137		Besancon Cedex		France
138		Colmar N/A		France
139		Metz		France
140		Nancy Cedex N/A		France
141		Nancy Cedex		France
142		Nimes		France
143		Paris		France
144		Vandoeuvre Les Nancy Cedex		France
145		Aachen		Germany
146		Bad Nauheim		Germany
147		Bad Segeberg		Germany
148		Bremen		Germany
149		Dresden		Germany
150		Eschweiler		Germany
151		Friedberg		Germany
152		Fulda		Germany
153		Hamburg		Germany
154		Kaltenkirchen		Germany
155		Magdeburg		Germany
156		Mannheim		Germany
157		Meißen		Germany
158		München		Germany
159		Münster		Germany
160		Pfaffenhofen		Germany
161		Radebeul		Germany
162		Schönebeck		Germany
163		Jerusalem		Israel
164		Ramat-Gan		Israel
165		Leeuwarden		Netherlands
166		Bedzin		Poland
167		Bielsko-Biala		Poland
168		Boleslawiec		Poland
169		Brzeg		Poland
170		Czestochowa		Poland
171		Gdansk N/A		Poland
172		Gdynia Poland		Poland
173		Gliwice N/A		Poland
174		Gorlice		Poland
175		Grojec		Poland
176		Jastrzebie-Zdroj		Poland
177		Katowice N/A		Poland
178		Katowice		Poland
179		Konin N/A		Poland
180		Konskie N/A		Poland
181		Koscierzyna		Poland
182		Krakow N/A		Poland
183		Lodz N/A		Poland
184		Nowy Dwor M		Poland
185		Nysa N/A		Poland
186		Opole N/A		Poland
187		Piotrkow Trybunalski		Poland
188		Poznan N/A		Poland
189		Radomsko		Poland
190		Ruda Slaska		Poland
191		Skierniewice		Poland
192		Swidnica		Poland
193		Tychy N/A		Poland
194		Ustron N/A		Poland
195		Warszawa N/A		Poland
196		Warszawa Poland		Poland
197		Warszawa		Poland
198		Wroclaw		Poland
199		Zabrze N/A		Poland
200		Zyrardow N/A		Poland
201		Bucuresti		Romania
202		Cluj Napoca		Romania
203		Iasi		Romania
204		Targu Mures		Romania
205		Arcadia Pretoria N/A		South Africa
206		Cape Town Western Province		South Africa
207		Roodepoort Central Gauteng		South Africa
208		Alicante N/A		Spain
209		Barcelona N/A		Spain
210		Barcelona		Spain
211		Madrid		Spain
212		Santander N/A		Spain
213		Santander		Spain
214		Santiago De Compostela N/A		Spain
215		Santiago De Compostela		Spain
216		Göteborg N/A		Sweden
217		Göteborg		Sweden
218		Basel N/A		Switzerland
219		Bruderholz N/A		Switzerland
220		Liestal		Switzerland
221		Antrim		United Kingdom
222		Belfast		United Kingdom
223		Brighton		United Kingdom
224		Chichester		United Kingdom
225		Durham		United Kingdom
226		Glasgow		United Kingdom
227		London		United Kingdom
228		Manchester		United Kingdom
229		Middlesbrough N/A		United Kingdom
230		Plymouth		United Kingdom
231		Portadown		United Kingdom
232		Southampton		United Kingdom
233		St Leonards On Sea		United Kingdom
234		Stockton On Tees		United Kingdom
235		Worthing		United Kingdom

Sponsors and Collaborators

• Centocor, Inc.
• Eli Lilly and Company

Investigators

• Study Director: Centocor, Inc. Clinical Trial, Centocor, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction - Finesse

Publications

None provided.

• Responsible Party: Centocor, Inc.
• ClinicalTrials.gov Identifier: NCT00046228
• Other Study ID Numbers: CR005410; FINESSE; CR005410
• First Posted: Sep 25, 2002
• Last Update Posted: Jul 31, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Centocor, Inc.: Myocardial infarction; percutaneous coronary intervention; abciximab; reteplase; safety and efficacy
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Reteplase; Tissue Plasminogen Activator; Abciximab

Study Results

Participant Flow

Recruitment Details	The study was conducted in 20 countries. The FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) study began enrollment in August 2002. It was planned that approximately 3,000 subjects would be enrolled. Because of enrollment difficulty, subject enrollment was stopped on 30 Dec 2006.
Pre-assignment Detail	A total of 2,461 subjects were enrolled in the study according to the sponsor's clinical trial management system. Out of 2461 subjects, 2,452 subjects were randomly assigned to the 3 treatment groups.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Period Title: 90 Days
STARTED	806	818	828
COMPLETED	793	810	813
NOT COMPLETED	13	8	15
Period Title: 90 Days
STARTED	806	818	828
COMPLETED	787	804	816
NOT COMPLETED	19	14	12

Baseline Characteristics

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group	Total
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI	Total of all reporting groups
Overall Participants	806	818	828	2452
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (11.4)	61.9 (11.8)	62.6 (11.4)	62.4 (11.5)
Sex: Female, Male (Count of Participants)
Female	207 25.7%	216 26.4%	219 26.4%	642 26.2%
Male	599 74.3%	602 73.6%	609 73.6%	1810 73.8%

Outcome Measures

1. Primary Outcome

Title	The Composite of All-Cause Mortality or Complications of MI at 90 Days.
Description	Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	806	818	828
Number [participants]	86 10.7%	86 10.5%	81 9.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.551
	Comments	The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.
	Method	Log Rank
	Comments	Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death & resuscitated v fib assessed by the investigator)
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	() 95%; 0.67 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.858
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	() 95%; 0.72 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.676
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.94
	Confidence Interval	() 95%; 0.69 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
Description	The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.
Time Frame	90 Days

Outcome Measure Data

Analysis Population Description

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	806	818	828
Number [participants]	72 8.9%	61 7.5%	61 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.247
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.81
	Confidence Interval	() 95%; 0.57 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.278
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.82
	Confidence Interval	() 95%; 0.58 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.944
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.99
	Confidence Interval	() 95%; 0.68 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	All-Cause Mortality Through 90 Days
Description	All cause mortality occurred through 90 days from randomization.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	806	818	828
Number [participants]	36 4.5%	45 5.5%	43 5.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.494
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.17
	Confidence Interval	() 95%; 0.74 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.338
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.25
	Confidence Interval	() 95%; 0.79 to 1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.781
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.94
	Confidence Interval	() 95%; 0.61 to 1.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
Time Frame	60 to 90 minutes

Outcome Measure Data

Analysis Population Description

Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	405	432	424
Number [participants]	75 9.3%	85 10.4%	108 13%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution >70% from baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.50
	Confidence Interval	() 95%; 1.08 to 2.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution >70% from baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.670
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.08
	Confidence Interval	() 95%; 0.76 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution >70% from baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.042
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.40
	Confidence Interval	() 95%; 1.01 to 1.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	All-Cause Mortality Through 1 Year
Description	All-cause mortality through 1 year from randomization.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	806	818	828
Number [participants]	56 6.9%	60 7.3%	52 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.603
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	() 95%; 0.62 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.765
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	() 95%; 0.73 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.415
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.86
	Confidence Interval	() 95%; 0.59 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Other Pre-specified Outcome

Title	Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7
Description	All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).
Time Frame	Discharge/Day 7

Outcome Measure Data

Analysis Population Description

The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	795	805	814
Number [participants]	1 0.1%	0 0%	5 0.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.218
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.497
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.062
	Comments
	Method	Fisher Exact
	Comments

7. Other Pre-specified Outcome

Title	Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7
Description	Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.
Time Frame	Discharge/Day 7

Outcome Measure Data

Analysis Population Description

The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	795	805	814
Number [participant]	55	81	118

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.28
	Confidence Interval	() 95%; 1.63 to 3.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.51
	Confidence Interval	() 95%; 1.05 to 2.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.52
	Confidence Interval	() 95%; 1.12 to 2.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Other Pre-specified Outcome

Title	Subjects With Severe Thrombocytopenia Through Discharge/Day 7
Description	Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.
Time Frame	Discharge/Day 7

Outcome Measure Data

Analysis Population Description

The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	795	805	814
Number [participants]	11 1.4%	16 2%	16 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.439
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.438
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.000
	Comments
	Method	Fisher Exact
	Comments

9. Other Pre-specified Outcome

Title	Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7
Time Frame	Discharge/Day 7

Outcome Measure Data

Analysis Population Description

The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	795	805	814
Number [participants]	139 17.2%	178 21.8%	271 32.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

10. Other Pre-specified Outcome

Title	Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7
Description	Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.
Time Frame	Discharge/Day 7

Outcome Measure Data

Analysis Population Description

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.

Arm/Group Title	Primary PCI Group	Abciximab Facilitated PCI Group	Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
Measure Participants	806	818	828
Number [participants]	128 15.9%	122 14.9%	120 14.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.434
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.90
	Confidence Interval	() 95%; 0.69 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Primary PCI Group, Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.589
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.93
	Confidence Interval	() 95%; 0.71 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Abciximab Facilitated PCI Group, Reteplase/Abciximab Facilitated PCI Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.809
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.97
	Confidence Interval	() 95%; 0.74 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Primary PCI Group		Abciximab Facilitated PCI Group		Reteplase/Abciximab Facilitated PCI Group
Arm/Group Description	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)		Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI		Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
All Cause Mortality
	Primary PCI Group		Abciximab Facilitated PCI Group		Reteplase/Abciximab Facilitated PCI Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Primary PCI Group		Abciximab Facilitated PCI Group		Reteplase/Abciximab Facilitated PCI Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	159/795 (20%)		182/805 (22.6%)		175/814 (21.5%)
Blood and lymphatic system disorders
Thrombocytopenia	1/795 (0.1%)		3/805 (0.4%)		1/814 (0.1%)
Hemoglobin decreased	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Anemia	1/795 (0.1%)		3/805 (0.4%)		0/814 (0%)
Anemia microcytic	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Leukopenia	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Anemia iron deficiency	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Cardiac disorders
Coronary stenosis	23/795 (2.9%)		38/805 (4.7%)		27/814 (3.3%)
Shock cardiogenic	4/795 (0.5%)		9/805 (1.1%)		13/814 (1.6%)
Unstable angina	4/795 (0.5%)		2/805 (0.2%)		6/814 (0.7%)
Myocardial infarction	6/795 (0.8%)		10/805 (1.2%)		5/814 (0.6%)
Angina pectoris	2/795 (0.3%)		3/805 (0.4%)		4/814 (0.5%)
Congestive heart failure	0/795 (0%)		3/805 (0.4%)		4/814 (0.5%)
Myocardial ischemia	1/795 (0.1%)		1/805 (0.1%)		4/814 (0.5%)
Cardiac failure	3/795 (0.4%)		5/805 (0.6%)		3/814 (0.4%)
Acute myocardial infarction	0/795 (0%)		3/805 (0.4%)		2/814 (0.2%)
Left ventricular dysfunction	0/795 (0%)		0/805 (0%)		2/814 (0.2%)
Chronic congestive heart failure	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Heart disorder	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Myocardial rupture	2/795 (0.3%)		2/805 (0.2%)		1/814 (0.1%)
Pericarditis	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Spiral coronary artery dissection	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Stable angina pectoris	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Tricuspid insufficiency	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Anginal pain	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Aortic stenosis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Coronary artery occlusion	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Coronary artery perforation	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Coronary in-stent restenosis	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Coronary restenosis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Endocarditis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Left ventricular ejection fraction decreased	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Mitral insufficiency	2/795 (0.3%)		0/805 (0%)		0/814 (0%)
Mitral regurgitation	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Pericardial effusion	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Ventricular septal defect	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Fibrillation ventricular	26/795 (3.3%)		21/805 (2.6%)		16/814 (2%)
Cardiac arrest	5/795 (0.6%)		2/805 (0.2%)		3/814 (0.4%)
Tachycardia ventricular	2/795 (0.3%)		5/805 (0.6%)		2/814 (0.2%)
AV block complete	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
AV block third degree	1/795 (0.1%)		1/805 (0.1%)		1/814 (0.1%)
Junctional bradycardia	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Nonsustained ventricular tachycardia	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Sinus bradycardia	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Arrhythmia supraventricular	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Arrhythmia ventricular	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Asystolia	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Atrial fibrillation	4/795 (0.5%)		2/805 (0.2%)		0/814 (0%)
Atrial fibrillation paroxysmal	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Atrial flutter	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
AV block second degree	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Bradycardia	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Cardiac arrhythmia nos	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Cardiac rhythm disturbance	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Cardiopulmonary arrest	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Electromechanical dissociation	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Intraventricular conduction defect	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Tachycardia atrial paroxysmal	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Ventricular bigeminy	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Ventricular febrillation paroxysm	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Atherosclerosis	14/795 (1.8%)		4/805 (0.5%)		14/814 (1.7%)
Hypotension	1/795 (0.1%)		0/805 (0%)		2/814 (0.2%)
Syncope	1/795 (0.1%)		2/805 (0.2%)		2/814 (0.2%)
Blood pressure high	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Hypertension	2/795 (0.3%)		0/805 (0%)		1/814 (0.1%)
Transient hypotension	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Collapse	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Hypertension arterial	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Hypovolemic shock	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Septic shock	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Shock	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Coronary artery dissection	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Ventricular aneurysm	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Cardiac tamponade	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Endocrine disorders
Hyperthyroidism	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Gastrointestinal disorders
Abdominal pain	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Diarrhea	1/795 (0.1%)		1/805 (0.1%)		1/814 (0.1%)
Diverticulitis	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Dysphagia	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Esophageal reflux	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Gastritis	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Ileus	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Intestinal Polyp	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Nontropical sprue	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Pancreatitis acute	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Preploric ulcer	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Digestion impaired	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Duodenal ulcer	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Epigastric pain	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Esophagitis	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Gastric ulcer	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Gastroesophageal reflux disease	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Intestinal obstruction	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Irritable bowel syndrome	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Stomach pain	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Stomach upset	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
General disorders
Chest pain	10/795 (1.3%)		19/805 (2.4%)		12/814 (1.5%)
Death	0/795 (0%)		2/805 (0.2%)		1/814 (0.1%)
Non-anginal pain	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Non-ischemic chest pain	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Allergic reaction	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Allergic reaction to diagnostic agent	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Incarcerated abdonimal hernia	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Inguinal hernia	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Interstitial fluid increased	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Intolerance induced	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Malaise	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Musculoskeletal pain	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Nontoxic drug overdose	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Pain	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Hepatobiliary disorders
Cholecystitis	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Gall bladder distention	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Hepatobiliary dysfunction	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Jaundice	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Infections and infestations
Cellulitis	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Fever	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Infection bacterial	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Influenza	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Urosepsis	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Wound healing impaired	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Wound infection	2/795 (0.3%)		1/805 (0.1%)		0/814 (0%)
Sepsis	1/795 (0.1%)		2/805 (0.2%)		1/814 (0.1%)
Metabolism and nutrition disorders
Hypercholesterolemia	1/795 (0.1%)		0/805 (0%)		2/814 (0.2%)
Adult onset diabetes mellitus	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Dehydration	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Diabetes mellitus	2/795 (0.3%)		0/805 (0%)		0/814 (0%)
Hyponatremia	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Musculoskeletal and connective tissue disorders
Aseptic necrosis bone	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Bone fracture	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Myalgia	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Skeletal pain	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Arthritis	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Synovitis	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Prostate cancer	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Pulmonary cancer	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Pulmonary carcinoma	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Rectal adenocarcinoma	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Rectal carcinoma	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Adenocarcinoma nos	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Breast carcinoma	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Ovarian cyst malignant	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Renal carcinoma	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Nervous system disorders
Epilepsy grand mal	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Pre-syncope	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Carpal tunnel syndrome	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Coma	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Dizziness	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Vasovagal reaction	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Psychiatric disorders
Anxiety	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Delirium tremens	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Renal and urinary disorders
Acute renal failure	2/795 (0.3%)		1/805 (0.1%)		4/814 (0.5%)
Urinary tract infection	1/795 (0.1%)		2/805 (0.2%)		2/814 (0.2%)
Chronic renal failure	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Creatinine increased	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Renal function decreased	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Urethral disorder nos	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Urinary retention	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Acute renal insufficiency	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Bladder stricture	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Nephritis	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Pyelonephritis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Renal failure	3/795 (0.4%)		1/805 (0.1%)		0/814 (0%)
Renal insufficiency	0/795 (0%)		2/805 (0.2%)		0/814 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	7/795 (0.9%)		8/805 (1%)		7/814 (0.9%)
Bronchopneumonia	2/795 (0.3%)		2/805 (0.2%)		3/814 (0.4%)
Pulmonary edema	3/795 (0.4%)		4/805 (0.5%)		3/814 (0.4%)
Respiratory arrest	0/795 (0%)		2/805 (0.2%)		2/814 (0.2%)
Respiratory failure	1/795 (0.1%)		3/805 (0.4%)		2/814 (0.2%)
Aspiration pneumonia	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Breathing difficult	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Bronchitis	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Chronic obstructive pulmonary disease	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Coughing	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Pleural effusion	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Pleuritis	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Pneumothorax	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Respiratory disorder	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Repiratory tract infection	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Respiratory tract lesion	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Adult respiratory distress syndrome	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Breathlessness	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Dyspnea	2/795 (0.3%)		2/805 (0.2%)		0/814 (0%)
Emphysema	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Lower respiratory tract infection	1/795 (0.1%)		2/805 (0.2%)		0/814 (0%)
Pleural exudate	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Pneumonia interstitial	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Breath shortness	1/795 (0.1%)		0/805 (0%)		2/814 (0.2%)
Skin and subcutaneous tissue disorders
Eruption	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Vascular disorders
Hemorrhagic stroke	0/795 (0%)		0/805 (0%)		2/814 (0.2%)
Gastric hemorrhage	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
GI hemorrhage	2/795 (0.3%)		1/805 (0.1%)		1/814 (0.1%)
GI hemorrhage - upper	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Hematoma	1/795 (0.1%)		1/805 (0.1%)		1/814 (0.1%)
Hemoptysis	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Hemorrhage nos	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Hematemesis	2/795 (0.3%)		0/805 (0%)		0/814 (0%)
Hemorrhage rectum	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Pulmonary hemorrhage	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Puncture site hematoma	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Retroperitoneal hemorrhage (type unknown)	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Vomiting blood	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Stroke	3/795 (0.4%)		2/805 (0.2%)		3/814 (0.4%)
Claudication intermittent	0/795 (0%)		0/805 (0%)		2/814 (0.2%)
Arterial stenosis	1/795 (0.1%)		0/805 (0%)		1/814 (0.1%)
Pseudoaneurysm	0/795 (0%)		1/805 (0.1%)		1/814 (0.1%)
Vasculitis	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Cerebral infarction	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Cerebrovascular accident	1/795 (0.1%)		3/805 (0.4%)		0/814 (0%)
Claudication	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Extracardiact arterial aneurysm	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Peripheral ischemia	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Phlebitis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Transient ischemic attack	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Thrombosis coronary artery	1/795 (0.1%)		0/805 (0%)		2/814 (0.2%)
Thrombosis cardiac chamber	0/795 (0%)		0/805 (0%)		1/814 (0.1%)
Atheroembolism limb	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Embolism pulmonary	2/795 (0.3%)		3/805 (0.4%)		0/814 (0%)
Thrombophlebitis	0/795 (0%)		1/805 (0.1%)		0/814 (0%)
Thrombosis venous deep	1/795 (0.1%)		1/805 (0.1%)		0/814 (0%)
Thrombosis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Venous thrombosis leg	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Left ventricular thrombus	2/795 (0.3%)		2/805 (0.2%)		2/814 (0.2%)
Phlebothrombosis	1/795 (0.1%)		0/805 (0%)		0/814 (0%)
Other (Not Including Serious) Adverse Events
	Primary PCI Group		Abciximab Facilitated PCI Group		Reteplase/Abciximab Facilitated PCI Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/795 (0%)		0/805 (0%)		0/814 (0%)

Limitations/Caveats

Some AEs were collected separately per protocol and are reported as "Other Pre-Specified Outcomes Measures".

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.