The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol

• Status: Completed
• Trial end date: 1999-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140 mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years. There was a risk reduction of 22% in the primary outcome (p=.0006) and 24% risk reduction in the combined endpoint of stroke, MI, and CHD death. The rate of events was reduced by raising HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med 1999;341:410-418).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: Fournier Labs; Parke-Davis
• Treatments: Gemfibrozil

Criteria

Inclusion Criteria:

Inclusion criteria:

1. male gender

2. age 73 or younger

3. presence of CHD

4. HDL-C le 40 mg/dl

5. LDL-C le 140 mg/dl

6. triglycerides le 300 mg/dl

Exclusion Criteria:

Exclusion criteria:

1. significant medical illness

2. alcohol or substance abuse

3. evidence of cholecystitis or cholelithiasis

4. ejection fraction of lt 35%

5. current use of steroids, estrogens, immunosuppressive agents, oral coagulants, or lipid modifying drug.

6. allergic to gemfibrozil or fibric acid

7. refused informed consent