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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2007

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.

Interventions

  • Drug: Ranolazine
    • IV to oral transition.
  • Drug: Placebo
    • IV to oral transition.

Arms, Groups and Cohorts

  • Experimental: 1
    • Ranolazine
  • Placebo Comparator: 2
    • Placebo

Clinical Trial Outcome Measures

Primary 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.
    • Time Frame: First occurrence

Secondary 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.
    • Time Frame: First occurence

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gilead Sciences
  • Collaborator
    • The TIMI Study Group
  • Provider of Information About this Clinical Study
    • Philip Sager, Vice President, Clinical Research, Gilead Sciences
  • Overall Official(s)
    • David A Morrow, MD, Principal Investigator, TIMI Study Group

References

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. doi: 10.1016/j.ahj.2006.01.004.

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