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

November 1, 2016 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

532

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z1
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
      • Victoria, British Columbia, Canada, V8R 4R2
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
      • Newmarket, Ontario, Canada, L3Y 2R2
      • Ottawa, Ontario, Canada, K1Y 4W7
      • Toronto, Ontario, Canada, M5G 1L7
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
      • Montreal, Quebec, Canada, H1T 1C8
      • Montréal, Quebec, Canada, H2W 1T8
      • Quebec City, Quebec, Canada, G1V 4G5
      • St-Charles Borromee, Quebec, Canada, J6E 6J2
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
      • Leeuwarden, Netherlands, 8934 AD
      • Nijmegen, Netherlands, 6525 GA
      • Rotterdam, Netherlands, 3079 DZ
      • Tilburg, Netherlands, 5042 AD
  • Poland
      • Bydgoszcz, Poland, 85-826
      • Gdansk, Poland, 80-952
      • Gdynia, Poland, 81-348
      • Jozefow, Poland, 05-410
      • Katowice, Poland, 40-635
      • Krakow, Poland, 31-202
      • Kraków, Poland, 31-501
      • Starogard Gdanski, Poland, 83-200
      • Torun, Poland, 87-100
      • Warszawa, Poland, 02-637
      • Warszawa, Poland, 04-628
      • Wejherowo, Poland, 84-200
      • Wroclaw, Poland, 50-981
      • Łodz, Poland, 91-347
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Tucson, Arizona, United States, 85710
    • California
      • Los Angeles, California, United States, 90022
      • Salinas, California, United States, 93901
    • Colorado
      • Littleton, Colorado, United States, 80120
    • Connecticut
      • Farmington, Connecticut, United States, 06030
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Kissimmee, Florida, United States, 34741
      • Ocala, Florida, United States, 34471
      • Sarasota, Florida, United States, 34239
      • St. Petersburg, Florida, United States, 33701
      • Tampa, Florida, United States, 33613
      • Vero Beach, Florida, United States, 32960
    • Georgia
      • Columbus, Georgia, United States, 31904
    • Illinois
      • Aurora, Illinois, United States, 60504
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Kentucky
      • Louisville, Kentucky, United States, 40205
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
    • Massachusetts
      • Baltimore, Massachusetts, United States, 21287
      • Hyannis, Massachusetts, United States, 02601
    • Michigan
      • Bay City, Michigan, United States, 48708
      • Petoskey, Michigan, United States, 49770
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
    • New York
      • Johnson City, New York, United States, 13790
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Ohio
      • Springfield, Ohio, United States, 45505
      • Toledo, Ohio, United States, 43606
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
      • Oklahoma City, Oklahoma, United States, 73120
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
    • Texas
      • Houston, Texas, United States, 77024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
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
Drug: RO4905417
20 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP25619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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