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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

March 30, 2011
November 24, 2014
May 2011
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01327183 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Myocardial Infarction
  • 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
  • Drug: placebo
    iv infusion, completed at least 1 hour and up to 24 hours before PCI
  • Experimental: 1
    Interventions:
    • Procedure: Percutaneous Coronary Intervention (PCI)
    • Drug: RO4905417
  • Experimental: 2
    Interventions:
    • Procedure: Percutaneous Coronary Intervention (PCI)
    • Drug: RO4905417
  • Placebo Comparator: 3
    Interventions:
    • Procedure: Percutaneous Coronary Intervention (PCI)
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
532
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
19 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Netherlands,   Poland
 
NCT01327183
BP25619
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP