RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Interventio

• Conditions: on-STEMI; MedDRA version: 14.1Level: LLTClassification code 10064348Term: Non STEMISystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001365-40-NL
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

Adult patients, > 18 years old and < 85 years
Non ST-elevation myocardial infarction
Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
Body mass index (BMI)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 459
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of RO4905417 in reducing the procedural<br>damage during PCI;Secondary Objective: To evaluate the changes in other cardiac and renal biomarkers<br>To evaluate the safety of RO4905417 by monitoring of adverse<br>events and the incidence of MACEs at 30 and 120 days after PCI<br>after a single dose of study drug;Primary end point(s): Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI ;Timepoint(s) of evaluation of this end point: from baseline to 24 hours post PCI

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline in troponin I at 8 hours post PCI Peak and AUC for troponin I<br>Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI <br>Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI <br>Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) ;Timepoint(s) of evaluation of this end point: from baseline to 120 days hours post PCI