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

Sponsor:	Gilead Sciences
Collaborator:	The TIMI Study Group
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00099788

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Heart Attack

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
1: Experimental Ranolazine	Drug: Ranolazine IV to oral transition.
2: Placebo Comparator 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:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Scirica BM, Morrow DA, Budaj A, Dalby AJ, Mohanavelu S, Qin J, Aroesty J, Hedgepeth CM, Stone PH, Braunwald E. Ischemia detected on continuous electrocardiography after acute coronary syndrome: observations from the MERLIN-TIMI 36 (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction 36) trial. J Am Coll Cardiol. 2009 Apr 21;53(16):1411-21.

Morrow DA, Scirica BM, Chaitman BR, McGuire DK, Murphy SA, Karwatowska-Prokopczuk E, McCabe CH, Braunwald E; MERLIN-TIMI 36 Investigators. Evaluation of the glycometabolic effects of ranolazine in patients with and without diabetes mellitus in the MERLIN-TIMI 36 randomized controlled trial. Circulation. 2009 Apr 21;119(15):2032-9. Epub 2009 Apr 6.

Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, Murphy SA, Budaj A, Varshavsky S, Wolff AA, Skene A, McCabe CH, Braunwald E; MERLIN-TIMI 36 Trial Investigators. Effects of ranolazine on recurrent cardiovascular events in patients with non-ST-elevation acute coronary syndromes: the MERLIN-TIMI 36 randomized trial. JAMA. 2007 Apr 25;297(16):1775-83.

Responsible Party:	Gilead Sciences ( Philip Sager, Vice President, Clinical Research )
Study ID Numbers:	CVT 3036, MERLIN TIMI 36
Study First Received:	December 21, 2004
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00099788 History of Changes
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:

Disease
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Ischemia

Pharmacologic Actions
Ranolazine
Pathologic Processes
Syndrome
Acute Coronary Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010