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

Last updated: November 1, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

2

Condition

Occlusions

Blood Clots

Angina

Treatment

N/A

Clinical Study ID

NCT01327183
BP25619
  • Ages 19-74
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 methodsof contraception

  • Body mass index (BMI) </= 40 kg/m2

Exclusion

Exclusion Criteria:

  • Acute ST-elevation myocardial infarction (STEMI)

  • Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring theuse 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, orimmuno-suppressed patients

  • Uncontrolled diabetes mellitus (HbA1C >10%) at baseline

Study Design

Total Participants: 532
Study Start date:
May 01, 2011
Estimated Completion Date:
October 31, 2012

Connect with a study center

  • Edmonton, Alberta T6G1Z1
    Canada

    Site Not Available

  • Vancouver, British Columbia V5Z 1L8
    Canada

    Site Not Available

  • Victoria, British Columbia V8R 4R2
    Canada

    Site Not Available

  • Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Newmarket, Ontario L3Y 2R2
    Canada

    Site Not Available

  • Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • empty

    Scarborough, Ontario M1E 4B9
    Canada

    Site Not Available

  • Toronto, Ontario M5G 1L7
    Canada

    Site Not Available

  • empty

    Joliette, Quebec J6E 6J2
    Canada

    Site Not Available

  • Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • empty

    Montréal, Quebec H2W 1T8
    Canada

    Site Not Available

  • Montréal, Quebec H2W 1T8
    Canada

    Site Not Available

  • Quebec City, Quebec G1V 4G5
    Canada

    Site Not Available

  • St-Charles Borromee, Quebec J6E 6J2
    Canada

    Site Not Available

  • Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Rotterdam, 3079 DZ
    Netherlands

    Site Not Available

  • Tilburg, 5042 AD
    Netherlands

    Site Not Available

  • empty

    ?odz, 91-347
    Poland

    Site Not Available

  • Bydgoszcz, 85-826
    Poland

    Site Not Available

  • Gdansk, 80-952
    Poland

    Site Not Available

  • Gdynia, 81-348
    Poland

    Site Not Available

  • Jozefow, 05-410
    Poland

    Site Not Available

  • Katowice, 40-635
    Poland

    Site Not Available

  • Krakow, 31-202
    Poland

    Site Not Available

  • empty

    Kraków, 310 507
    Poland

    Site Not Available

  • Kraków, 31-501
    Poland

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  • empty

    Lodz, 91-347
    Poland

    Site Not Available

  • empty

    ODZ, 91-347
    Poland

    Site Not Available

  • Starogard Gdanski, 83-200
    Poland

    Site Not Available

  • Torun, 87-100
    Poland

    Site Not Available

  • Warszawa, 02-637
    Poland

    Site Not Available

  • Wejherowo, 84-200
    Poland

    Site Not Available

  • Wroclaw, 50-981
    Poland

    Site Not Available

  • Łodz, 91-347
    Poland

    Site Not Available

  • Huntsville, Alabama 35801
    United States

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    Scottsdale, Arizona 85025
    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

    Site Not Available

  • Littleton, Colorado 80120
    United States

    Site Not Available

  • Farmington, Connecticut 06030
    United States

    Site Not Available

  • Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Kissimmee, Florida 34741
    United States

    Site Not Available

  • Ocala, Florida 34471
    United States

    Site Not Available

  • Sarasota, Florida 34239
    United States

    Site Not Available

  • St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Tampa, Florida 33613
    United States

    Site Not Available

  • Vero Beach, Florida 32960
    United States

    Site Not Available

  • Columbus, Georgia 31904
    United States

    Site Not Available

  • Aurora, Illinois 60504
    United States

    Site Not Available

  • Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Iowa City, Iowa 52242
    United States

    Site Not Available

  • Wichita, Kansas 67214
    United States

    Site Not Available

  • Louisville, Kentucky 40205
    United States

    Site Not Available

  • Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Baltimore, Massachusetts 21287
    United States

    Site Not Available

  • Hyannis, Massachusetts 02601
    United States

    Site Not Available

  • Bay City, Michigan 48708
    United States

    Site Not Available

  • Petoskey, Michigan 49770
    United States

    Site Not Available

  • St. Paul, Minnesota 55102
    United States

    Site Not Available

  • empty

    Washington, Missouri 63090
    United States

    Site Not Available

  • Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Johnson City, New York 13790
    United States

    Site Not Available

  • empty

    New York, New York 10128
    United States

    Site Not Available

  • Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Springfield, Ohio 45505
    United States

    Site Not Available

  • Toledo, Ohio 43606
    United States

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  • Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Chambersburg, Pennsylvania 17201
    United States

    Site Not Available

  • Houston, Texas 77024
    United States

    Site Not Available

  • empty

    San Antonio, Texas 78229
    United States

    Site Not Available

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