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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01327183
First received: March 30, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in troponin I at 8 hours post PCI [ Time Frame: from baseline to 8 hours post PCI ] [ Designated as safety issue: No ]
  • Peak and AUC for troponin I [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: No ]
  • Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI [ Time Frame: from baseline to 24 hours post PCI ] [ Designated as safety issue: No ]
  • Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI [ Time Frame: from baseline to Day 120 post PCI ] [ Designated as safety issue: No ]
  • Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI [ Time Frame: from baseline to Day 30 post PCI ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Enrollment: 532
Study Start Date: May 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4905417
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Procedure: Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
Experimental: 2 Drug: RO4905417
20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Procedure: Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
Placebo Comparator: 3 Drug: placebo
iv infusion, completed at least 1 hour and up to 24 hours before PCI
Procedure: Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion

  Eligibility

Ages Eligible for Study:   19 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327183

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Tucson, Arizona, United States, 85710
United States, California
Los Angeles, California, United States, 90022
Salinas, California, United States, 93901
United States, Colorado
Littleton, Colorado, United States, 80120
United States, Connecticut
Farmington, Connecticut, United States, 06030
United States, 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
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Illinois
Aurora, Illinois, United States, 60504
United States, Indiana
Fort Wayne, Indiana, United States, 46804
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Louisville, Kentucky, United States, 40205
United States, Louisiana
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Baltimore, Massachusetts, United States, 21287
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Bay City, Michigan, United States, 48708
Petoskey, Michigan, United States, 49770
United States, Minnesota
St. Paul, Minnesota, United States, 55102
United States, New Jersey
Ridgewood, New Jersey, United States, 07450
United States, New York
Johnson City, New York, United States, 13790
United States, North Carolina
Raleigh, North Carolina, United States, 27610
United States, North Dakota
Bismarck, North Dakota, United States, 58501
United States, Ohio
Springfield, Ohio, United States, 45505
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73120
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Chambersburg, Pennsylvania, United States, 17201
United States, Texas
Houston, Texas, United States, 77024
Canada, Alberta
Edmonton, Alberta, Canada, T6L5X8
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
Newmarket, Ontario, Canada, L3Y 2R2
Ottawa, Ontario, Canada, K1Y 4W7
Toronto, Ontario, Canada, M5G 1L7
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H4J 1C5
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
Lodz, Poland, 91-347
Starogard Gdanski, Poland, 83-200
Torun, Poland, 87-100
Warszawa, Poland, 04-628
Warszawa, Poland, 02-637
Wejherowo, Poland, 84-200
Wroclaw, Poland, 50-981
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01327183     History of Changes
Other Study ID Numbers: BP25619
Study First Received: March 30, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014