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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

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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:

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