Status:
COMPLETED
Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
The TIMI Study Group
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tr...
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 ration...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
6560 Patients enrolled
Trial Details
Trial ID
NCT00099788
Start Date
October 1 2004
End Date
February 1 2007
Last Update
November 26 2009
Active Locations (1)
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1
The TIMI Study Group
Boston, Massachusetts, United States, 02115