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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00099788

Collaborator

The TIMI Study Group (Other)

6,560

Enrollment

Location

Arms

Duration (Months)

234.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia	Drug: Ranolazine Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

6560 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multinational, Clinical Trial to Evaluate the Efficacy and Safety of Ranolazine vs Placebo in Patients With Non-ST Segment Elevation Acute Coronary Syndromes

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Ranolazine	Drug: Ranolazine IV to oral transition. Other Names: Ranexa
Placebo Comparator: 2 Placebo	Drug: Placebo IV to oral transition.

Arm

Intervention/Treatment

Experimental: 1

Ranolazine

Drug: Ranolazine

IV to oral transition.

Other Names:

Ranexa

Placebo Comparator: 2

Placebo

Drug: Placebo

IV to oral transition.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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