SISCA: Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation

• Sponsor: Hospital Avicenne (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00445263
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 2
• Duration (Months): 76
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

Condition or Disease	Intervention/Treatment	Phase
CORONARY DISEASE	Drug: TIROFIBAN; Procedure: CORONAROGRAPHY	Phase 4

Detailed Description

Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of > 1 mm; transient elevation of the ST segment > 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score > 5

Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Invasive strategy Tirofiban and coronarography within 6 hours	Drug: TIROFIBAN; intravenous infusion; Other Names: IIb/IIIa GP inhibitor ; Procedure: CORONAROGRAPHY; standard procedure of coronarography; Other Names: angiography
Active Comparator: Delayed invasive strategy Coronarography after 6 hours	Procedure: CORONAROGRAPHY; standard procedure of coronarography; Other Names: angiography

Outcome Measures

Primary Outcome Measures

1. Mortality, Myocardial Infarction and Revascularization in Emergency [d30]

Secondary Outcome Measures

1. Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography [until the exit from the hospital and at d30.]

2. Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus [d30]

3. Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications. [d30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• High risk ACS without ST elevation

Exclusion Criteria:

• Age <18 years

• Pregnancy

• Persistence of the ST elevation

• Recent left branch block

• Cardiac failure or cardiogenic shock (Kilip 3 or 4)

• Treatment by anti-vitamin K

• Contra-indication to the use of one of the following treatments: aspirin, clopidogrel, enoxaparine, anti GP IIb/IIIa (tirofiban)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samu 93 - Chu Avicenne	Bobigny	Ile de France	France	93000

Sponsors and Collaborators

• Hospital Avicenne

Investigators

• Principal Investigator: FREDERIC LAPOSTOLLE, MD, SAMU 93 - AVICENNE HOSPITAL
• Study Director: FREDERIC ADNET, PHD, SAMU 93 - AVICENNE HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FREDERIC LAPOSTOLLE, Frédéric Lapostolle, Hospital Avicenne
• ClinicalTrials.gov Identifier: NCT00445263
• Other Study ID Numbers: PC/AP 39-2005
• First Posted: Mar 8, 2007
• Last Update Posted: Feb 27, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by FREDERIC LAPOSTOLLE, Frédéric Lapostolle, Hospital Avicenne: CORONARY DISEASE
• Additional relevant MeSH terms: Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease; Tirofiban

Study Results

Participant Flow

Arm/Group Title	Early Invasive Strategy	Delayed Invasive Strategy
Arm/Group Description	Tirofiban and coronarography within six hours	Coronarography after six hours
Period Title: Overall Study
STARTED	83	87
COMPLETED	83	86
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Early Invasive Strategy	Delayed Invasive Strategy	Total
Arm/Group Description	Tirofiban and coronarography within six hours	Coronarography after six hours	Total of all reporting groups
Overall Participants	83	86	169
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	63.9	66.5	65.3
Sex: Female, Male (Count of Participants)
Female	25 30.1%	23 26.7%	48 28.4%
Male	58 69.9%	63 73.3%	121 71.6%
BMI (kg/m2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m2]	27.0	26.6	26.6
Family history of CVS disease (participants) [Number]
Yes	20 24.1%	22 25.6%	42 24.9%
No	63 75.9%	64 74.4%	127 75.1%
Current smoker (participants) [Number]
Yes	44 53%	41 47.7%	85 50.3%
No	39 47%	45 52.3%	84 49.7%
Diabetes mellitus (participants) [Number]
Yes	35 42.2%	28 32.6%	63 37.3%
No	48 57.8%	58 67.4%	106 62.7%
Hypertension (participants) [Number]
Yes	50 60.2%	51 59.3%	101 59.8%
No	33 39.8%	35 40.7%	68 40.2%
Dyslipidemia (participants) [Number]
Yes	45 54.2%	45 52.3%	90 53.3%
No	38 45.8%	41 47.7%	79 46.7%
Previous MI (participants) [Number]
Yes	19 22.9%	20 23.3%	39 23.1%
No	64 77.1%	66 76.7%	130 76.9%
Previous PCI (participants) [Number]
Yes	20 24.1%	18 20.9%	38 22.5%
No	63 75.9%	68 79.1%	131 77.5%
Previous CABG (participants) [Number]
Yes	8 9.6%	4 4.7%	12 7.1%
No	75 90.4%	82 95.3%	157 92.9%
On aspirin (participants) [Number]
Yes	39 47%	32 37.2%	71 42%
No	44 53%	54 62.8%	98 58%

Outcome Measures

1. Primary Outcome

Title	Mortality, Myocardial Infarction and Revascularization in Emergency
Time Frame	d30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Early Invasive Strategy	Delayed Invasive Strategy
Arm/Group Description	Tirofiban and coronarography within six hours	Coronarography after six hours
Measure Participants	83	86
Number [participants]	2 2.4%	21 24.4%

2. Secondary Outcome

Title	Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography
Time Frame	until the exit from the hospital and at d30.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus
Time Frame	d30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.
Time Frame	d30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	30 days
Arm/Group Title	Early Invasive Strategy		Delayed Invasive Strategy
Arm/Group Description	Tirofiban and coronarography within six hours		Coronarography after six hours
All Cause Mortality
	Early Invasive Strategy		Delayed Invasive Strategy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Early Invasive Strategy		Delayed Invasive Strategy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/83 (2.4%)		1/86 (1.2%)
General disorders
Major bleeding	2/83 (2.4%)		1/86 (1.2%)
Other (Not Including Serious) Adverse Events
	Early Invasive Strategy		Delayed Invasive Strategy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/86 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.