Prevention of Renal and Vascular Endstage Disease Intervention Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 864
- 主要终点
- Combined incidence of all-cause mortality, MACE and/or end-stage renal disease
研究概览
简要总结
The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.
详细描述
This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (RR <160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol <8.0 or <5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion >10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascular ENdstage Disease Intervention Trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •Persistent microalbuminuria (urinary albumin excretion >10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples)
- •No hypertension (RR <160/100 mm Hg, no anti-hypertensive medication)
- •No hypercholesterolemia (total cholesterol <8.0 or <5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication)
排除标准
- •Creatinine clearance >60% of the normal age-adjusted value
- •Serum potassium >5.5 mmol/L
- •History of chronic liver disease
- •Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase >3 times the upper limit of normal
- •Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists
- •Use of insulin
- •Previously documented allergy or intolerance to study drugs
- •Pregnant or nursing women
研究组 & 干预措施
Fosinopril + Pravastatin
Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
干预措施: Fosinopril (Drug)
Fosinopril + Pravastatin
Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
干预措施: Pravastatin (Drug)
Fosinopril + Placebo
Fosinopril (20 mg) + pravastatin placebo once daily for 4 years
干预措施: Fosinopril (Drug)
Fosinopril + Placebo
Fosinopril (20 mg) + pravastatin placebo once daily for 4 years
干预措施: Pravastatin Placebo (Drug)
Pravastatin + Placebo
Pravastatin (40 mg) + fosinopril placebo once daily for 4 years
干预措施: Pravastatin (Drug)
Pravastatin + Placebo
Pravastatin (40 mg) + fosinopril placebo once daily for 4 years
干预措施: Fosinopril Placebo (Drug)
Double Placebo
Fosinopril placebo and pravastatin placebo once daily for 4 years
干预措施: Fosinopril Placebo (Drug)
Double Placebo
Fosinopril placebo and pravastatin placebo once daily for 4 years
干预措施: Pravastatin Placebo (Drug)
结局指标
主要结局
Combined incidence of all-cause mortality, MACE and/or end-stage renal disease
时间窗: 4 years
Combined incidence of all-cause mortality or hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease
次要结局
- Incidence of hospital admission(4 years)
- Incidence of all-cause mortality(4 years)
- effect of treatment on microalbuminuria(4 years)
- effect of treatment on LDL cholesterol(4 years)
- effect of treatment on blood pressure(4 years)
研究者
Prof. Wiek H. van Gilst
Principal Investigator
University Medical Center Groningen