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

This study has been completed.
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00099788
First received: December 21, 2004
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Myocardial Ischemia
 Drug: Ranolazine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Ranolazine
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

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. [ Time Frame: First occurrence ] [ Designated as safety issue: No ]

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. [ Time Frame: First occurence ] [ Designated as safety issue: No ]

Enrollment: 6560
Study Start Date: October 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ranolazine
 Drug: Ranolazine
IV to oral transition.
Other Name: Ranexa
Placebo Comparator: 2
Placebo
 Drug: Placebo
IV to oral transition.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099788

Locations
United States, Massachusetts
The TIMI Study Group
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Gilead Sciences
The TIMI Study Group
Investigators
Principal Investigator: David A Morrow, MD TIMI Study Group
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00099788     History of Changes
Other Study ID Numbers: CVT 3036, MERLIN TIMI 36
Study First Received: December 21, 2004
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Acute Coronary Syndrome
Myocardial Infarction
Heart Attack
Angina
 Chest pain
Ischemia
Non-ST Elevation Acute Coronary Syndrome

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
 Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013