STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.
研究概览
简要总结
This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins"
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a drug and determine whether the investigational drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The chemotherapy drug that the participant have been scheduled to be treated with, Doxorubicin, has been associated with the development of heart failure in some patients.
This research study is testing whether Atorvastatin can protect the hearts of patients being treated with Doxorubicin and can reduce cardiac injury and the risk of heart failure. Atorvastatin is not approved by the FDA (the U.S. Food and Drug Administration) for use to reduce the cardiac injury after Doxorubicin. Atorvastatin is approved by the FDA for lowering cholesterol and for reducing the risk of heart attack and stroke. The heart is a muscle that pumps blood and Atorvastatin may protect the heart by preserving cardiac muscle function.
The investigators will test whether atorvastatin protects the heart using a combination of imaging tests on the participants heart, blood tests, and stress testing. The imaging tests will involve an echocardiogram (an echo) and cardiac magnetic resonance (CMR), a type of magnetic resonance imaging (MRI) scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •All patients with newly diagnosed NHL and HL
- •Scheduled to receive anthracycline-based therapy
排除标准
- •Statin use or Statin use is indicated based on guidelines
- •Pregnancy or breastfeeding
- •Unable to provide informed consent
- •Unexplained persistent elevation of transaminases (>3 times upper limits of normal)
- •Concomitant use of cyclosporine
- •Renal failure: estimated glomerular filtration <45 mL/min/1.73 m2
- •Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular clip
- •LVEF of <50% at baseline
研究组 & 干预措施
Placebo
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
干预措施: Placebo (Drug)
Atorvastatin
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
干预措施: Atorvastatin (Drug)
结局指标
主要结局
The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.
时间窗: 12 months
To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of\>10% from prior to chemotherapy to a final value of \<55% over 12 months.
次要结局
- The Percentage of Participants in Each Group With New Onset Heart Failure.(2 years)
- Myocardial Extracellular Volume by Cardiac MRI.(1 Year)
- Global Longitudinal Strain (GLS)(1 year)
研究者
Tomas G. Neilan, MD
MD
Massachusetts General Hospital