Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 51
- 主要终点
- Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
The purpose of this research study is to see if Atorvastatin (Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in individuals receiving adjuvant anthracycline-based chemotherapy for breast cancer of lymphoma.
详细描述
PRIMARY OBJECTIVES:
Specific Aim 1:
To determine if Atorvastatin(Lipitor) administration preserves left ventricular ejection fraction (LVEF) 24 months after initiation of Anthracycline-based adjuvant therapy for adjuvant treatment of breast cancer or lymphoma.
Specific Aim 2:
To determine if baseline to 6-month differences in LVEF predict baseline to 24-month differences in LVEF after Anthracycline-based adjuvant therapy and concomitant atorvastatin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma Stage I-IV. (Patients should have a > 2 year life expectancy)
- •Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin)
- •21 years of age or older
- •LVEF > 50% (Most recent within the last 5 years)
- •Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment
- •Patients that are receiving or have received chemotherapy regimens are allowed
- •Able to hold breath for 10 seconds
- •Prior cancers allowed if no evidence of disease in last 5 years
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
排除标准
- •Prior use of lipid-lowering therapy within the last 6 months
- •Current postmenopausal hormone-replacement therapy
- •Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- •Scheduled to receive neoadjuvant chemotherapy with an anthracycline
- •No active liver disease allowed
- •Uncontrolled hypothyroidism
- •Recent history (within past 3 years) of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, use of immunosuppressant agents, or another medical condition that might compromise safety or the successful completion of the study.
- •Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal;pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
- •Unstable angina; significant ventricular arrhythmias (>20 premature ventricular complexes (PVCs)/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response; coronary artery disease; acute myocardial infarction within 28 days
- •Current use of Cytochrome P450 (CYP3A4) inhibitors. These include Clarithromycin, HIV protease inhibitors, Itraconazole, grapefruit juice, Cyclosporine, Rifampin or Digoxin
- •Current or history of hepatic dysfunction
- •Unable to provide informed consent
- •Claustrophobia
- •Planning to move within 24 months of trial enrollment
- •Pregnant or breast-feeding
研究组 & 干预措施
Arm 1 - Atorvastatin
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
干预措施: Atorvastatin (Drug)
Arm 2 - Placebo
One placebo tablet each morning by mouth for 24 months.
干预措施: Atorvastatin (Drug)
Arm 2 - Placebo
One placebo tablet each morning by mouth for 24 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Left Ventricular Ejection Fraction (LVEF)
时间窗: 24 months
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular ejection fraction by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
次要结局
- Left Ventricular (LV) Mass(24 months)
- Hopkins Verbal Learning Test (HVLT) Total Recall(24 months)
- End Diastolic Volume(24 months)
- End Systolic Volume(24 months)
- Pulse Wave Velocity(24 months)
- Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Fatigue Short Form 41(24 months)
- Stroke Volume(24 months)
- Controlled Oral Word Association (COWA)(24 months)
- Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Applied Cognition - General Concerns - Short Form 4a(24 months)