Merlin Study

Study of:

Ranolazine is an investigational new drug (not yet approved for use by health authorities) that is being studied for the treatment of angina (angina refers to chest pain that typically occurs with activity and goes away with rest). It works differently than current anti-anginals. Ranolazine also has anti-ischemia properties (ischemia refers to decreased blood flow due to obstruction of the blood vessels). These properties have been shown (in previous studies) to reduce myocardial ischemia and improve exercise performance in patients with stable coronary artery disease. This effect does not depend on changes in blood pressure, heart rate, AV nodal conduction, or contractile function. Observations from studies in animals and humans support the hypothesis that when added to standard therapy for a patient with unstable angina (different chest pain than a patient with angina would normally have) or a certain type of myocardial infarction (determined by ECG reading), ranolazine will improve outcomes.

Patients enrolled in this study will receive an intravenous dose of ranolazine for 12 to 96 hours while they are in the hospital.

The intravenous dose will be followed up with Ranolazine taken in a pill form two times a day for the duration of the study (up to approximately 24 months).

Patient’s study involvement is as follows:

• Medical history, a full physical examination and an electrocardiogram (ECG – an electrical recording of your heart rate and rhythm), a short questionnaire asking about quality of life before coming to the hospital.
• Blood Draws (including pregnancy test)
• A heart monitor that can be worn in the hospital and at home will be placed on subjects chest and will monitor your electrocardiogram continuously for 7 days.
• Clinic visits at 2 weeks after starting the study, and then at 4 months, 8 months, and every 4 months thereafter until the study ends. Visits may include symptom review, medication review, physical exam, ECG, blood tests, and quality of life questionnaires.
• An exercise tolerance test (on the treadmill) is completed by subjects at approximately 8 months after starting study drug, (or the end of the study, whichever comes sooner).
• Telephone call after the end of the study to see if they have had any side-effects that may be related to the study medication.

Patients that qualify for the Merlin study have to be diagnosed by their doctor as having blockage in an artery to their heart. The blockage may be new, leading to a diagnosis of myocardial infarction, or unstable angina.

M. Nicholas Burke, MD

Holly MacDonald, RN

For more information about this study or the Acute Coronary Syndromes Research program at the Minneapolis Heart Institute Foundation, please call Carol Stone at 612-863-9124.