Status:
WITHDRAWN
Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease
Lead Sponsor:
Colorado Prevention Center
Conditions:
Peripheral Arterial Disease
Angina
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Study Endpoints: Primary Endpoint: • The primary endpoint of this study is the change in the kinetics of tissue hemoglobin oxygen desaturation (expressed as time constants) following the onset of ex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00657514
Start Date
May 1 2008
End Date
June 1 2009
Last Update
August 15 2014
Active Locations (3)
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1
University of Colorado at Denver
Aurora, Colorado, United States, 80045
2
Denver Health and Hospital Authority (DHHA)
Denver, Colorado, United States, 80204
3
Department of Veteran Affairs Medical Center
Denver, Colorado, United States, 80220