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)

Phase 2

Completed

Conditions: non- STEMI / Myocardial Infarction
10028593

Registration Number: NL-OMON35644

Lead Sponsor: Roche Nederland B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. Patients > 18 years old and < 85 years
2. Patients must be diagnosed with Non STEMI event
3. Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
4. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy objective of this study is:<br /><br>• To evaluate the efficacy of RO4905417 in reducing the procedural damage<br /><br>during PCI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy and safety objectives of this study are:<br /><br>• To evaluate the changes in other cardiac and renal biomarkers<br /><br>• To evaluate the safety of RO4905417 by monitoring of adverse events and the<br /><br>incidence of MACEs at 30 and 120 days after PCI after a single dose of study<br /><br>drug </p><br>