NCT03073018

Prevention of Renal and Vascular Endstage Disease Intervention Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 864 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Microalbuminuria
• Cardiovascular Diseases
• Renal Disease

Interventions

Type	Name	Description
DRUG	Fosinopril	oral administration, capsules
DRUG	Pravastatin	oral administration, capsules
DRUG	Fosinopril Placebo	oral administration, capsules
DRUG	Pravastatin Placebo	oral administration, capsules

Timeline

• Start date: 1998-04-01
• Primary completion: 2003-06-01
• Completion: 2003-11-01
• First posted: 2017-03-08
• Last updated: 2017-03-10