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

This study has been completed.
Sponsor:
Collaborators:
Parke-Davis
Fournier Labs
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00283335
First received: January 25, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Department of Veterans Affairs:

Primary Outcome Measures:
  • incidence of nonfatal myocardial infarction or death from coronary heart disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 73 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00283335

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

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00283335     History of Changes
Other Study ID Numbers: 363
Study First Received: January 25, 2006
Last Updated: October 31, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014