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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327183
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Percutaneous Coronary Intervention (PCI) Drug: RO4905417 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : May 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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
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
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



Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327183


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche