METABOLIC EFFICIENCY WITH RANOLAZINE FOR LESS ISCHEMIA IN NON-ST ELEVATION ACUTE CORONARY SYNDROMES A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, MULTINATIONAL, CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RANOLAZINE VERSUS PLACEBO IN PATIENTS WITH NON-ST SEGMENT ELEVATION ACUTE CORONARY SYNDROMES - MERLIN-TIMI 36

• Conditions: MedDRA version: 7.0Level: PTClassification code 10051592; on-ST Elevation Acute Coronary Syndrome

• Registration Number: EUCTR2004-001090-25-AT
• Lead Sponsor: CV THERAPEUTICS INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-15
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

All inclusion criteria must be met:-
1) Aged 18 years or older, and
2) Hospitalisation with non-ST elevation acute coronary syndrome defined as chest discomfort or anginal equivalent occurring at rest, lasting for 10 minutes or more and consistent with myocardial ischemia, and
3) At least one episode of ischemic symptoms (5 minutes or longer) at rest within 48 hours of enrollment (may include index episode), and
4) At least one of the indicators of moderate-high risk as detailed in the protocol, and
5) Willing and able to provide written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any of the criteria will result in exclusion:-
1) Persistent (> 20 mins) acute ST-segment elevation of 0.1 mV or greater, in two or more contiguous leads
2) Successful revascularisation of the culprit stenosis during the qualifying hospitalisation prior to randomisation
3) Acute pulmonary edema requiring endotracheal intubation, sustained blood pressure < 90 mm Hg or evidence of cardiogenic shock
4) Left bundle branch block, electronic pacemaker, or LVH with severe repolarizartion abnormality that would interfere with interpretation of the Holter
5) Other exclusion criteria in the Protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified