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

NCT00283335 | Completed Phase 3 DMC

• 1 other identifier: 363
• Study Type: interventional
• Target: 2,531
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• incidence of nonfatal myocardial infarction or death from coronary heart disease

  5 years

Study Arms (2)

Gemfibrozil

ACTIVE COMPARATOR

1200 mg slow-release gemfibrozil (Lopid-SR) once per day

Drug: gemfibrozil

Placebo

PLACEBO COMPARATOR

Matching placebo tablets taken once per day

Other: Placebo

Interventions

gemfibrozil DRUG

Gemfibrozil

Placebo OTHER

Matching placebo tablets taken once per day

Placebo

Eligibility Criteria

• Age: Up to 73 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Parke-Davis: collaborator
• Fournier Labs: collaborator

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (5)

• Brousseau ME, O'Connor JJ Jr, Ordovas JM, Collins D, Otvos JD, Massov T, McNamara JR, Rubins HB, Robins SJ, Schaefer EJ. Cholesteryl ester transfer protein TaqI B2B2 genotype is associated with higher HDL cholesterol levels and lower risk of coronary heart disease end points in men with HDL deficiency: Veterans Affairs HDL Cholesterol Intervention Trial. Arterioscler Thromb Vasc Biol. 2002 Jul 1;22(7):1148-54. doi: 10.1161/01.atv.0000024566.57589.2e.

  PMID: 12117730 RESULT

• Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med. 1999 Aug 5;341(6):410-8. doi: 10.1056/NEJM199908053410604.

  PMID: 10438259 RESULT

• Rubins HB, Robins SJ, Collins D, Nelson DB, Elam MB, Schaefer EJ, Faas FH, Anderson JW. Diabetes, plasma insulin, and cardiovascular disease: subgroup analysis from the Department of Veterans Affairs high-density lipoprotein intervention trial (VA-HIT). Arch Intern Med. 2002 Dec 9-23;162(22):2597-604. doi: 10.1001/archinte.162.22.2597.

  PMID: 12456232 RESULT

• Papademetriou V, Narayan P, Rubins H, Collins D, Robins S. Influence of risk factors on peripheral and cerebrovascular disease in men with coronary artery disease, low high-density lipoprotein cholesterol levels, and desirable low-density lipoprotein cholesterol levels. HIT Investigators. Department of Veterans Affairs HDL Intervention Trial. Am Heart J. 1998 Oct;136(4 Pt 1):734-40. doi: 10.1016/s0002-8703(98)70023-7.

  PMID: 9778079 RESULT

• Rubins HB, Robins SJ, Collins D. The Veterans Affairs High-Density Lipoprotein Intervention Trial: baseline characteristics of normocholesterolemic men with coronary artery disease and low levels of high-density lipoprotein cholesterol. Veterans Affairs Cooperative Studies Program High-Density Lipoprotein Intervention Trial Study Group. Am J Cardiol. 1996 Sep 1;78(5):572-5. doi: 10.1016/s0002-9149(96)00369-4.

  PMID: 8806347 RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

Gemfibrozil

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Hanna E. Bloomfield, MD MPH

  Minneapolis VA Health Care System, Minneapolis, MN

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2006
• First Posted: January 27, 2006
• Study Start: June 1, 1991
• Primary Completion: September 1, 1998
• Study Completion: August 1, 1999
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)