Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will change compared to placebo in patients with chronic angina and peripheral arterial disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colorado Prevention Center
• Treatments: Ranolazine

Criteria

Inclusion Criteria:

• Males age > 40 years.

• Subjects must have chronic stable angina, meeting the labeled indications for ranolazine:

Ranolazine is indicated for the treatment of chronic angina. Ranolazine should be reserved for subjects who have not achieved an adequate response with other anti-anginal drugs.

• Subjects must have a resting ankle brachial index (ABI) of < 0.90 with a post-exercise decrement of ≥ 10% in at least one leg, OR a resting ABI of ≥0.90 to ≤ 1.00 with a post-exercise decrement of ≥ 20% in at least one leg

• The subject has provided written informed consent to participate, understands the requirements of the study, and agrees to return for the required assessments

Exclusion Criteria:

• Non-atherosclerotic diseases of the peripheral circulation by clinical history

• Unable to complete the first stage of the modified, extended Astrand treadmill protocol

• Clinically significant ECG abnormalities or changes with exercise on the screening ECG

• Evidence of critical limb ischemia (CLI)

• Hepatic impairment (Child-Pugh Classes A [mild], B [moderate], or C [severe])

• End stage renal disease requiring dialysis

• Hemoglobin < 12 mg/dL.

• Platelet count < 90,000/mL.

• Planned surgical/endovascular intervention for coronary artery disease (CAD) or peripheral arterial disease (PAD) in the next 3 months

• Maximal exercise is limited by symptoms other than claudication or angina

• Significant mental illness or drug abuse within 30 days of enrollment that in the opinion of the Investigator could impact the subject's ability to successfully complete the trial

• Known allergy to ranolazine

• Pre-existing QTc prolongation on a resting electrocardiogram (ECG) at Screening due to the risk of worsening of this condition with the use of ranolazine

• Treatment with QT prolonging drugs such as Class IA (e.g. quinidine) and Class III (e.g. sotalol, dofetilide), antiarrhythmics, amiodarone, and antipsychotics (e.g. thioridazine, ziprasidone)

• Treatment with potent or moderately potent CYP3A inhibitors including ketoconazole and other azole antifungals, diltiazem, verapamil, macrolide antibiotics, cyclosporine, or human immunodeficiency virus (HIV) protease inhibitors

• The subject has previously received ranolazine within the 6-months prior to enrollment

• The subject has received an investigational drug within 90 days prior to enrollment

• Type 1 or type 2 diabetes mellitus

• Congestive Heart Failure, ≥ New York Heart Association (NYHA) Class III

• History of oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)

• Body Mass Index (BMI) >35