Harvard Atherosclerosis Reversibility Project (HARP)

NCT00000461 | Completed Phase 2

• 2 other identifiers: 50R01HL036392
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Interventions

pravastatin DRUG

niacin DRUG

cholestyramine DRUG

gemfibrozil DRUG

fatty acids, omega-3 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men and women, normocholesterolemic, with 30 percent or greater narrowing of a coronary artery lumen as revealed by angiography. (Cholesterol-Lowering Agent Trial). Men and women with angiographically-documented coronary heart disease (Fish Oil Tr

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (4)

• Sacks FM, Pasternak RC, Gibson CM, Rosner B, Stone PH. Effect on coronary atherosclerosis of decrease in plasma cholesterol concentrations in normocholesterolaemic patients. Harvard Atherosclerosis Reversibility Project (HARP) Group. Lancet. 1994 Oct 29;344(8931):1182-6. doi: 10.1016/s0140-6736(94)90506-1.

  PMID: 7934538 BACKGROUND

• Sacks FM, Stone PH, Gibson CM, Silverman DI, Rosner B, Pasternak RC. Controlled trial of fish oil for regression of human coronary atherosclerosis. HARP Research Group. J Am Coll Cardiol. 1995 Jun;25(7):1492-8. doi: 10.1016/0735-1097(95)00095-l.

  PMID: 7759696 BACKGROUND

• Sacks FM, Gibson CM, Rosner B, Pasternak RC, Stone PH. The influence of pretreatment low density lipoprotein cholesterol concentrations on the effect of hypocholesterolemic therapy on coronary atherosclerosis in angiographic trials. Harvard Atherosclerosis Reversibility Project Research Group. Am J Cardiol. 1995 Sep 28;76(9):78C-85C. doi: 10.1016/s0002-9149(99)80475-5.

  PMID: 7572692 BACKGROUND

• Pasternak RC, Brown LE, Stone PH, Silverman DI, Gibson CM, Sacks FM. Effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. A randomized, placebo-controlled trial. Harvard Atherosclerosis Reversibility Project (HARP) Study Group. Ann Intern Med. 1996 Oct 1;125(7):529-40. doi: 10.7326/0003-4819-125-7-199610010-00001.

  PMID: 8815751 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Interventions

Pravastatin; Niacin; Cholestyramine Resin; Gemfibrozil; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Fatty Acids, Volatile; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fish Oils; Oils

Study Officials

• Frank Sacks

  Brigham and Women's Hospital

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: December 1, 1986
• Study Completion: November 1, 1992
• Last Updated: March 16, 2016

Record last verified: 2005-03