NCT00657514撤回4 期
Evaluation of Ranolazine on Skeletal Muscle Endpoints During Exercise In Subjects With Chronic Angina and Peripheral Arterial Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- skeletal muscle hemoglobin desaturation kinetics
研究概览
简要总结
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.
详细描述
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 exercise.
Secondary endpoints of this study include percent and absolute change in:
- Peak oxygen consumption
- Pulmonary oxygen uptake on-kinetics
- Steady state level of tissue hemoglobin desaturation during exercise
- Recovery kinetics of tissue oxygen saturation following exercise
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
A
Active Comparator
Drug arm - 500mg tablet po bid up to 1000mg (2 500mg tablets) po bid
干预措施: Ranolazine (Drug)
P
Placebo Comparator
Placebo arm - 1 tablet po bid up to 2 tablets po bid if tolerated
干预措施: Placebo (Drug)
结局指标
主要结局
skeletal muscle hemoglobin desaturation kinetics
时间窗: 6 weeks
次要结局
- peak exercise oxygen consumption(6 weeks)
- Claudication Onset Time (COT)(6 weeks)
- Time to Onset of Angina (TOA)(6 weeks)
- Pulmonary oxygen uptake on-kinetics(6 weeks)
- Steady state level of tissue hemoglobin desaturation during exercise(6 weeks)
- Recovery kinetics of tissue oxygen saturation following exercise(6 weeks)
- adverse events(6 weeks)
- Peak Walking Time (PWT)(6 weeks)
研究者
Mark Nehler, MD
Chief, Section of Vascular Surgery and EndoVascular Therapy and Podiatry
Colorado Prevention Center
研究点 (3)
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