The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
Completed · Phase 3 · Has a placebo group
Conditions studied: Coronary Heart Disease
In brief
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).
Key facts
- Study ID
- NCT00283335
- Run by
- VA Office of Research and Development
- People needed
- 2531
- Starts
- 1991-06-01
- Expected to finish
- 1999-08-01
- Last updated by the study team
- 2015-10-21
Who can join
Age: any, up to 73. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion criteria:
- male gender
- age 73 or younger
- presence of CHD
- HDL-C le 40 mg/dl
- LDL-C le 140 mg/dl
- triglycerides le 300 mg/dl
You may not qualify if…
- Exclusion criteria:
- significant medical illness
- alcohol or substance abuse
- evidence of cholecystitis or cholelithiasis
- ejection fraction of lt 35%
- current use of steroids, estrogens, immunosuppressive agents, oral coagulants, or lipid modifying drug.
- allergic to gemfibrozil or fibric acid
- refused informed consent
Where it is running
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.