A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01327183

Collaborator

(none)

532

Enrollment

Locations

Arms

17.1

Duration (Months)

8.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Procedure: Percutaneous Coronary Intervention (PCI) Drug: RO4905417 Drug: RO4905417 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

532 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20 mg/kg RO4905417 before PCI	Procedure: Percutaneous Coronary Intervention (PCI) at least 1 hour and up to 24 hours after completion of drug infusion Drug: RO4905417 20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Experimental: 5 mg/kg RO4905417 before PCI	Procedure: Percutaneous Coronary Intervention (PCI) at least 1 hour and up to 24 hours after completion of drug infusion Drug: RO4905417 5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Placebo Comparator: Placebo before PCI	Procedure: Percutaneous Coronary Intervention (PCI) at least 1 hour and up to 24 hours after completion of drug infusion Drug: placebo iv infusion, completed at least 1 hour and up to 24 hours before PCI

Arm

Intervention/Treatment

Experimental: 20 mg/kg RO4905417 before PCI

Procedure: Percutaneous Coronary Intervention (PCI)

at least 1 hour and up to 24 hours after completion of drug infusion

Drug: RO4905417

20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI

Experimental: 5 mg/kg RO4905417 before PCI

Procedure: Percutaneous Coronary Intervention (PCI)

at least 1 hour and up to 24 hours after completion of drug infusion

Drug: RO4905417

5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI

Placebo Comparator: Placebo before PCI

Procedure: Percutaneous Coronary Intervention (PCI)

at least 1 hour and up to 24 hours after completion of drug infusion

Drug: placebo

iv infusion, completed at least 1 hour and up to 24 hours before PCI

Outcome Measures

Primary Outcome Measures

Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI [from baseline to 24 hours post PCI]

Secondary Outcome Measures

Change from baseline in troponin I at 8 hours post PCI [from baseline to 8 hours post PCI]
Peak and AUC for troponin I [24 hours post PCI]
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI [from baseline to 24 hours post PCI]
Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI [from baseline to Day 120 post PCI]
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI [from baseline to Day 30 post PCI]
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) [120 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients, >18 to <75 years of age
Non ST-elevation myocardial infarction
Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
Body mass index (BMI) </= 40 kg/m2

Exclusion Criteria:

Acute ST-elevation myocardial infarction (STEMI)
Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
Percutaneous coronary intervention (PCI) within the past 72 hours
Thrombolytic therapy within the past 7 days
Major surgery within the past 3 months
History of cerebral vascular disease or stroke in the past 3 months
Bleeding disorders
Inadequately controlled severe hypertension
Prior coronary artery bypass graft (CABG) surgery
Decompensated heart failure (oedema and/or rale)
Acute infection at screening or active chronic infection within 3 months prior to PCI
Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
Uncontrolled diabetes mellitus (HbA1C >10%) at baseline

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Huntsville	Alabama	United States	35801
2	Tucson	Arizona	United States	85710
3	Los Angeles	California	United States	90022
4	Salinas	California	United States	93901
5	Littleton	Colorado	United States	80120
6	Farmington	Connecticut	United States	06030
7	Boynton Beach	Florida	United States	33472
8	Kissimmee	Florida	United States	34741
9	Ocala	Florida	United States	34471
10	Sarasota	Florida	United States	34239
11	St. Petersburg	Florida	United States	33701
12	Tampa	Florida	United States	33613
13	Vero Beach	Florida	United States	32960
14	Columbus	Georgia	United States	31904
15	Aurora	Illinois	United States	60504
16	Fort Wayne	Indiana	United States	46804
17	Iowa City	Iowa	United States	52242
18	Wichita	Kansas	United States	67214
19	Louisville	Kentucky	United States	40205
20	Shreveport	Louisiana	United States	71103
21	Baltimore	Massachusetts	United States	21287
22	Hyannis	Massachusetts	United States	02601
23	Bay City	Michigan	United States	48708
24	Petoskey	Michigan	United States	49770
25	St. Paul	Minnesota	United States	55102
26	Ridgewood	New Jersey	United States	07450
27	Johnson City	New York	United States	13790
28	Raleigh	North Carolina	United States	27610
29	Bismarck	North Dakota	United States	58501
30	Springfield	Ohio	United States	45505
31	Toledo	Ohio	United States	43606
32	Oklahoma City	Oklahoma	United States	73109
33	Oklahoma City	Oklahoma	United States	73120
34	Chambersburg	Pennsylvania	United States	17201
35	Houston	Texas	United States	77024
36	Edmonton	Alberta	Canada	T6G1Z1
37	Vancouver	British Columbia	Canada	V5Z 1L8
38	Victoria	British Columbia	Canada	V8R 4R2
39	Hamilton	Ontario	Canada	L8L 2X2
40	Newmarket	Ontario	Canada	L3Y 2R2
41	Ottawa	Ontario	Canada	K1Y 4W7
42	Toronto	Ontario	Canada	M5G 1L7
43	Montreal	Quebec	Canada	H1T 1C8
44	Montreal	Quebec	Canada	H4J 1C5
45	Montréal	Quebec	Canada	H2W 1T8
46	Quebec City	Quebec	Canada	G1V 4G5
47	St-Charles Borromee	Quebec	Canada	J6E 6J2
48	Heerlen		Netherlands	6419 PC
49	Leeuwarden		Netherlands	8934 AD
50	Nijmegen		Netherlands	6525 GA
51	Rotterdam		Netherlands	3079 DZ
52	Tilburg		Netherlands	5042 AD
53	Bydgoszcz		Poland	85-826
54	Gdansk		Poland	80-952
55	Gdynia		Poland	81-348
56	Jozefow		Poland	05-410
57	Katowice		Poland	40-635
58	Krakow		Poland	31-202
59	Kraków		Poland	31-501
60	Starogard Gdanski		Poland	83-200
61	Torun		Poland	87-100
62	Warszawa		Poland	02-637
63	Warszawa		Poland	04-628
64	Wejherowo		Poland	84-200
65	Wroclaw		Poland	50-981
66	Łodz		Poland	91-347

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01327183

Other Study ID Numbers:

BP25619

First Posted:

Apr 1, 2011

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Myocardial Infarction

Non-ST Elevated Myocardial Infarction

Infarction

Study Results

No Results Posted as of Nov 2, 2016