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)

Hoffmann-La Roche0 sites532 target enrollmentMay 2011

ConditionsMyocardial Infarction

InterventionsPercutaneous Coronary Intervention (PCI)RO4905417 placebo

DrugsRO4905417 placebo

Overview

Phase: Phase 2
Intervention: Percutaneous Coronary Intervention (PCI)
Conditions: Myocardial Infarction
Sponsor: Hoffmann-La Roche
Enrollment: 532
Primary Endpoint: Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

October 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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)

Arms & Interventions

20 mg/kg RO4905417 before PCI

Intervention: Percutaneous Coronary Intervention (PCI)

20 mg/kg RO4905417 before PCI

Intervention: RO4905417

5 mg/kg RO4905417 before PCI

Intervention: Percutaneous Coronary Intervention (PCI)

5 mg/kg RO4905417 before PCI

Intervention: RO4905417

Placebo before PCI

Intervention: Percutaneous Coronary Intervention (PCI)

Placebo before PCI

Intervention: placebo

Outcomes

Primary Outcomes

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 Outcomes

Change from baseline in troponin I at 8 hours post PCI(from baseline to 8 hours post PCI)
Peak and AUC for troponin I(24 hours post PCI)
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI(from baseline to 24 hours post PCI)
Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI(from baseline to Day 120 post PCI)
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI(from baseline to Day 30 post PCI)
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)(120 days)