Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4,110
- 试验地点
- 30
- 主要终点
- Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events
研究概览
简要总结
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.
详细描述
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 - 75 years old
- •Had kidney transplant at least 6 months
- •Calculated Creatinine Clearance must be 25 mL/min or greater
- •Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit
排除标准
- •If pregnant or lactating
- •If of child bearing potential and not on birth control
- •If any of the following will limit life expectancy to less than 2 yrs:
- •Congestive heart failure (CHF) (end stage)
- •Liver disease (end stage)
- •Severe pulmonary disease
- •Progressive HIV
- •Any other chronic wasting illness
- •If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
- •If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
- •If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
- •If patient has had multi-organ transplant, except kidney/pancreas
研究组 & 干预措施
High Dose Multivitamin
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
干预措施: High Dose Multivitamin (Drug)
Low Dose Multivitamin
Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12
干预措施: Low Dose Multivitamin (Device)
结局指标
主要结局
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events
时间窗: Up to 6 years (mean 4 years)
次要结局
- Fatal/Non-fatal Myocardial Infarction (MI)(Up to 6 years (mean 4 years))
- CVD Death(Up to 6 years (mean 4 years))
- Coronary Artery Revascularization(Up to 6 years (mean 4 years))
- Resuscitated Sudden Death (RSD)(Up to 6 years (mean 4 years))
- Renal Artery Revascularization(Up to 6 years (mean 4 years))
- Renal Graft Failure(Up to 6 years (mean 4 years))
- Mortality (All-cause)(Up to 6 years (mean 4 years))
- Fatal/Non-fatal Stroke(Up to 6 years (mean 4 years))
- Lower Extremity Peripheral Arterial Disease (PAD)(Up to 6 years (mean 4 years))
- Carotid Endarterectomy or Angioplasty(Up to 6 years (mean 4 years))
- Abdominal Aortic Aneurysm Repair(Up to 6 years (mean 4 years))