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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: November 24, 2014
Last verified: November 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
Procedure: Percutaneous Coronary Intervention (PCI)
Drug: RO4905417
Drug: placebo
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 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
Experimental: 2 Procedure: Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
Drug: RO4905417
20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Placebo Comparator: 3 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

  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

  Show 66 Study Locations
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: November 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014