We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283335
First Posted: January 27, 2006
Last Update Posted: October 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Parke-Davis
Fournier Labs
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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).

Condition Intervention Phase
Coronary Heart Disease Drug: gemfibrozil Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #363 - The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • incidence of nonfatal myocardial infarction or death from coronary heart disease [ Time Frame: 5 years ]

Enrollment: 2531
Study Start Date: June 1991
Study Completion Date: August 1999
Primary Completion Date: September 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gemfibrozil
1200 mg slow-release gemfibrozil (Lopid-SR) once per day
Drug: gemfibrozil
Placebo Comparator: Placebo
Matching placebo tablets taken once per day
Other: Placebo
Matching placebo tablets taken once per day

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 73 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283335


Locations
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
VA Office of Research and Development
Parke-Davis
Fournier Labs
Investigators
Study Chair: Hanna E. Bloomfield, MD MPH Minneapolis VA Health Care System, Minneapolis, MN
  More Information

Publications:
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.
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.
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.
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.
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.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00283335     History of Changes
Other Study ID Numbers: 363
First Submitted: January 25, 2006
First Posted: January 27, 2006
Last Update Posted: October 21, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors


To Top