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

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: Percutaneous Coronary Intervention (PCI); Drug: RO4905417; Drug: placebo

• Registration Number: NCT01327183
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Study Start: 2011-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Disposition First Submitted: 2016-07-08
• Disposition First Submitted QC: 2016-07-08
• Disposition First Posted: 2016-07-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 mg/kg RO4905417 before PCI	RO4905417	-
20 mg/kg RO4905417 before PCI	Percutaneous Coronary Intervention (PCI)	-
5 mg/kg RO4905417 before PCI	RO4905417	-
Placebo before PCI	Percutaneous Coronary Intervention (PCI)	-
5 mg/kg RO4905417 before PCI	Percutaneous Coronary Intervention (PCI)	-
Placebo before PCI	placebo	-

Primary Outcome Measures

Name	Time	Method
Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI	from baseline to 24 hours post PCI

Secondary Outcome Measures

Name	Time	Method
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