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

Myocardial Ischemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099788
• Other study ID #: CVT 3036
• Secondary ID: MERLIN TIMI 36
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2004
• Last updated: November 24, 2009
• Start date: October 2004
• Est. completion date: February 2007

Study information

• Verified date: November 2009
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6560
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	The TIMI Study Group	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	The TIMI Study Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

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