METABOLIC EFFICIENCY WITH RANOLAZINE FOR LESS ISCHEMIA IN NON-ST ELEVATION ACUTE CORONARY SYNDROMES A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, MULTINATIONAL, CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RANOLAZINE VERSUS PLACEBO IN PATIENTS WITH NON-ST SEGMENT ELEVATION ACUTE CORONARY SYNDROMES - MERLIN-TIMI 36

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001090-25-DE

Enrollment

6500

Registered

2004-10-12

Start date

2004-12-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST Segment Elevation Acute Coronary Syndrome MedDRA version: 8.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome

Interventions

Product Name: RANOLAZINE Product Code: CVT-303 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RANOLAZINE CAS Number: 95635-55-5 Current Sponsor code: CVT-303 Other descriptive name: Ra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All inclusion criteria must be met:- 1) Aged 18 years or older, and 2) Hospitalisation with non-ST elevation acute coronary syndrome defined as chest discomfort or anginal equivalent occurring at rest, lasting for 10 minutes or more and consistent with myocardial ischemia, and 3) At least one episode of ischemic symptoms (5 minutes or longer) at rest within 48 hours of enrollment (may include index episode), and 4) At least one of the indicators of moderate-high risk as detailed in the protocol, and 5) Willing and able to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any of the criteria will result in exclusion:- 1) Persistent (> 20 mins) acute ST-segment elevation of 0.1 mV or greater, in two or more contiguous leads 2) Successful revascularisation of the culprit stenosis during the qualifying hospitalisation prior to randomisation 3) Acute pulmonary edema requiring endotracheal intubation, sustained blood pressure < 90 mm Hg or evidence of cardiogenic shock 4) Left bundle branch block, electronic pacemaker, or LVH with severe repolarizartion abnormality that would interfere with interpretation of the Holter 5) Other exclusion criteria in the Protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether ranolazine is superior to placebo for reducing the rate of CV death, MI, or severe recurrent ischemia during long term treatment of patients with non-ST elevation acute coronary syndrome receiving standard therapy ;Primary end point(s): Primary Efficacy Endpoint is the time to first occurence of any element of the composite of CV death, MI or recurrent ischemia. Other endpoints in the Protocol ;Secondary Objective: 1) To determine whether ranolazine is superior to placebo for reducing the rate of major cardiovascular events (CV death, MI, or severe recurrent ischemia) during long term treatment of patients with non-ST elevation acute coronary syndrome receiving standard therapy 2) To determine whether ranolazine is superior to placebo for reducing the rate of failure of therapy (CV death, MI, recurrent ischemia, positive Holter for ischemia, hospitalisation for new/worsening heart failure or an early positive exercise test) during long term treatment of patients with non-ST elevation acute coronary syndrome receiving standard therapy 3) To evaluate the safety of treatment with ranolazine compared to placebo 4) Other secondary objectives as detailed in the Protocol (refer to Protocol section 4)	—

Measure

Time frame

Main Objective: To determine whether ranolazine is superior to placebo for reducing the rate of CV death, MI, or severe recurrent ischemia during long term treatment of patients with non-ST elevation acute coronary syndrome receiving standard therapy ;Primary end point(s): Primary Efficacy Endpoint is the time to first occurence of any element of the composite of CV death, MI or recurrent ischemia. Other endpoints in the Protocol ;Secondary Objective: 1) To determine whether ranolazine is superior to placebo for reducing the rate of major cardiovascular events (CV death, MI, or severe recurrent ischemia) during long term treatment of patients with non-ST elevation acute coronary syndrome receiving standard therapy 2) To determine whether ranolazine is superior to placebo for reducing the rate of failure of therapy (CV death, MI, recurrent ischemia, positive Holter for ischemia, hospitalisation for new/worsening heart failure or an early positive exercise test) during long term treatment of patients with non-ST elevation acute coronary syndrome receiving standard therapy 3) To evaluate the safety of treatment with ranolazine compared to placebo 4) Other secondary objectives as detailed in the Protocol (refer to Protocol section 4)

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Countries

Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026