A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
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)
1 other identifier
interventional
532
4 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 2, 2016
November 1, 2016
1.4 years
March 30, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
20 mg/kg RO4905417 before PCI
EXPERIMENTAL5 mg/kg RO4905417 before PCI
EXPERIMENTALPlacebo before PCI
PLACEBO COMPARATORInterventions
at least 1 hour and up to 24 hours after completion of drug infusion
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Unknown Facility
Huntsville, Alabama, 35801, United States
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Tucson, Arizona, 85710, United States
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Los Angeles, California, 90022, United States
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Salinas, California, 93901, United States
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Littleton, Colorado, 80120, United States
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Farmington, Connecticut, 06030, United States
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Boynton Beach, Florida, 33472, United States
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Kissimmee, Florida, 34741, United States
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Ocala, Florida, 34471, United States
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Sarasota, Florida, 34239, United States
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St. Petersburg, Florida, 33701, United States
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Tampa, Florida, 33613, United States
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Vero Beach, Florida, 32960, United States
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Columbus, Georgia, 31904, United States
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Aurora, Illinois, 60504, United States
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Fort Wayne, Indiana, 46804, United States
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Iowa City, Iowa, 52242, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40205, United States
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Shreveport, Louisiana, 71103, United States
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Baltimore, Massachusetts, 21287, United States
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Hyannis, Massachusetts, 02601, United States
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Bay City, Michigan, 48708, United States
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Petoskey, Michigan, 49770, United States
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Saint Paul, Minnesota, 55102, United States
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Ridgewood, New Jersey, 07450, United States
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Johnson City, New York, 13790, United States
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Raleigh, North Carolina, 27610, United States
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Bismarck, North Dakota, 58501, United States
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Springfield, Ohio, 45505, United States
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Toledo, Ohio, 43606, United States
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Oklahoma City, Oklahoma, 73109, United States
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Oklahoma City, Oklahoma, 73120, United States
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Chambersburg, Pennsylvania, 17201, United States
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Houston, Texas, 77024, United States
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Edmonton, Alberta, T6G1Z1, Canada
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Vancouver, British Columbia, V5Z 1L8, Canada
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Victoria, British Columbia, V8R 4R2, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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Newmarket, Ontario, L3Y 2R2, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Toronto, Ontario, M5G 1L7, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Heerlen, 6419 PC, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3079 DZ, Netherlands
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Tilburg, 5042 AD, Netherlands
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Bydgoszcz, 85-826, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-348, Poland
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Józefów, 05-410, Poland
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Katowice, 40-635, Poland
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Krakow, 31-202, Poland
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Krakow, 31-501, Poland
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Lodz, 91-347, Poland
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Starogard Gdański, 83-200, Poland
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Torun, 87-100, Poland
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Warsaw, 02-637, Poland
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Warsaw, 04-628, Poland
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Wejherowo, 84-200, Poland
Unknown Facility
Wroclaw, 50-981, Poland
Related Publications (2)
Stahli BE, Gebhard C, Duchatelle V, Cournoyer D, Petroni T, Tanguay JF, Robb S, Mann J, Guertin MC, Wright RS, L L'Allier P, Tardif JC. Effects of the P-Selectin Antagonist Inclacumab on Myocardial Damage After Percutaneous Coronary Intervention According to Timing of Infusion: Insights From the SELECT-ACS Trial. J Am Heart Assoc. 2016 Nov 16;5(11):e004255. doi: 10.1161/JAHA.116.004255.
PMID: 27852589DERIVEDTardif JC, Tanguay JF, Wright SR, Duchatelle V, Petroni T, Gregoire JC, Ibrahim R, Heinonen TM, Robb S, Bertrand OF, Cournoyer D, Johnson D, Mann J, Guertin MC, L'Allier PL. Effects of the P-selectin antagonist inclacumab on myocardial damage after percutaneous coronary intervention for non-ST-segment elevation myocardial infarction: results of the SELECT-ACS trial. J Am Coll Cardiol. 2013 May 21;61(20):2048-55. doi: 10.1016/j.jacc.2013.03.003. Epub 2013 Mar 10.
PMID: 23500230DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 1, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11