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: April 7, 2014
Last verified: April 2014
  Purpose

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.


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
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: April 7, 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 April 16, 2014