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

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ClinicalTrials.gov Identifier: NCT00099788
Recruitment Status : Completed
First Posted : December 21, 2004
Last Update Posted : November 26, 2009
The TIMI Study Group
Information provided by:
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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Ranolazine

Arm Intervention/treatment
Experimental: 1
Drug: Ranolazine
IV to oral transition.
Other Name: Ranexa

Placebo Comparator: 2
Drug: Placebo
IV to oral transition.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099788

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United States, Massachusetts
The TIMI Study Group
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Gilead Sciences
The TIMI Study Group
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Principal Investigator: David A Morrow, MD TIMI Study Group
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00099788    
Other Study ID Numbers: CVT 3036
First Posted: December 21, 2004    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: November 2009
Keywords provided by Gilead Sciences:
Acute Coronary Syndrome
Myocardial Infarction
Heart Attack
Chest pain
Non-ST Elevation Acute Coronary Syndrome
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action