Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes

Phase 3

Completed

• Conditions: Myocardial Ischemia
• Interventions: Drug: Placebo; Drug: Ranolazine

• Registration Number: NCT00099788
• Lead Sponsor: Gilead Sciences

Brief Summary

MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.

Detailed Description

Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, Skene A, McCabe CH, Braunwald E; MERLIN-TIMI 36 Investigators. Evaluation of a novel anti-ischemic agent in acute coronary syndromes: design and rationale for the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-elevation acute coronary syndromes (MERLIN)-TIMI 36 trial. Am Heart J. 2006 Jun;151(6):1186.e1-9.

Study Timeline

• Study Start: 2004-10
• Study First Submitted QC: 2004-12-20
• Study First Submitted: 2004-12-21
• Study First Posted: 2004-12-21
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6560

Inclusion Criteria

• Hospitalized with non-ST elevation acute coronary syndrome
• Ischemic symptoms (more than or equal to 5 minutes) at rest within 48 hours of study entry
• At least one additional risk factor (e.g., elevated cardiac enzymes, ST-depression, diabetes)

Exclusion Criteria

• Persistent acute ST-segment elevation
• Successful revascularization during the qualifying hospitalization, prior to study entry
• Acute pulmonary edema, hypotension, or evidence of cardiogenic shock
• Clinically significant liver disease
• End stage kidney disease requiring dialysis
• Concomitant use of drugs known to prolong the QT interval, or any digitalis drugs
• Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4
• Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control

Additional study entry criteria will be evaluated during initial screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Ranolazine	Ranolazine

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS.	First occurrence

Secondary Outcome Measures

Name	Time	Method
Composite of cardiovascular death, myocardial infarction, or severe recurrent ischemia. Safety of long-term treatment with ranolazine compared to placebo; safety endpoints are death from any cause and symptomatic documented arrhythmia.	First occurence

Trial Locations

Locations (1)

The TIMI Study Group; 🇺🇸 Boston, Massachusetts, United States