A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
NCT ID: NCT01327183
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
532 participants
INTERVENTIONAL
2011-05-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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20 mg/kg RO4905417 before PCI
Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
RO4905417
20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
5 mg/kg RO4905417 before PCI
Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
RO4905417
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Placebo before PCI
Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
placebo
iv infusion, completed at least 1 hour and up to 24 hours before PCI
Interventions
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Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
RO4905417
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
RO4905417
20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
placebo
iv infusion, completed at least 1 hour and up to 24 hours before PCI
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
74 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Huntsville, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Salinas, California, United States
Littleton, Colorado, United States
Farmington, Connecticut, United States
Boynton Beach, Florida, United States
Kissimmee, Florida, United States
Ocala, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Columbus, Georgia, United States
Aurora, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Massachusetts, United States
Hyannis, Massachusetts, United States
Bay City, Michigan, United States
Petoskey, Michigan, United States
Saint Paul, Minnesota, United States
Ridgewood, New Jersey, United States
Johnson City, New York, United States
Raleigh, North Carolina, United States
Bismarck, North Dakota, United States
Springfield, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Chambersburg, Pennsylvania, United States
Houston, Texas, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Hamilton, Ontario, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Heerlen, , Netherlands
Leeuwarden, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Tilburg, , Netherlands
Bydgoszcz, , Poland
Gdansk, , Poland
Gdynia, , Poland
Józefów, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Starogard Gdański, , Poland
Torun, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wejherowo, , Poland
Wroclaw, , Poland
Countries
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References
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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.
Tardif 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.
Other Identifiers
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BP25619
Identifier Type: -
Identifier Source: org_study_id