MARS - Monitored Atherosclerosis Regression Study

NCT00116870 | Completed Phase 2

• 2 other identifiers: AG0027MK-803
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether significant alterations in serum lipoproteins as provided by the drug lovastatin can substantially reduce atherosclerosis progression or even induce regression.

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

CAD; familial hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• the average (per-patient) change from baseline in percent diameter stenosis in all lesions that showed 20% diameter stenosis at baseline or at follow-up as evaluated by quantitative coronary angiography

Secondary Outcomes (3)

• average (per-patient) change in minimum lumen diameter assessed by quantitative angiography

• the global change score assessed by a human panel

• the proportion of patients with progression or regression of disease assessed by quantitative coronary angiography

Interventions

lovastatin DRUG

Eligibility Criteria

• Age: 21 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Angiography within 17 weeks of randomization showing patient is at high risk for coronary artery disease but not a candidate for coronary artery graft surgery
• Men and women ages 21 through 67 years
• Mean plasma cholesterol levels from the first two screening visits in the range of 190 to 270 mg/dL
• Smokers are admitted, but encouraged to stop smoking tobacco

You may not qualify if:

• Premenopausal women unless surgically sterilized
• Hypertension, diabetes, thyroid disease, liver dysfunction, renal insufficiency, congestive heart failure, major arrhythmia, left ventricular conduction defects
• Physical impairment that may interfere with participation
• Life threatening disease with high likelihood of disability or death during the trial period
• Use of hydralazine, guanethidine, lipid-lowering drugs, estrogens, steroids, amphetamines, antibiotics, theophylline, acetaminophen (average daily use greater than ten grains), other drugs as determined by the principle investigator
• Vitamins A or D in doses greater than the Recommended Daily Allowance (RDA)
• Alcohol abuse
• Nutritional supplements high in cholesterol content
• Chelation therapy
• Psychosocial situations which make completion of the study unlikely
• Hypersensitivity to any component of the study medication

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Hyperlipoproteinemia Type II

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Howard N. Hodis, MD

  University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 1, 2005
• Study Start: June 1, 1985
• Primary Completion: February 1, 1992
• Study Completion: February 1, 1992
• Last Updated: December 11, 2009

Record last verified: 2005-06

Locations

US (1)