MARS - Monitored Atherosclerosis Regression Study

December 9, 2009 updated by: Merck Sharp & Dohme LLC

A Double-Blind, Placebo-Controlled Angiographic Study to Evaluate the Effect of Lovastatin on the Progression Rate of Atherosclerosis in the Coronary Arteries of Patients With Coronary Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two conceptual advances occurring in the 1980's made it possible to test the hypothesis that significant alterations in serum lipoproteins can substantially reduce atherosclerosis progression or even induce regression. The first advance was in the development of arteriograms used in characterizing atherosclerosis, greatly reducing the number of patients required for the evaluation of an intervention designed to prevent coronary atherosclerosis progression. The second advance was the development of lovastatin that provides a lipid-lowering alternative much easier to tolerate than the niacin/colestipol combination previously used, and has been shown to be comparably effective for LDL reduction in patients with a family history of high cholesterol.

A total of 270 high-risk coronary artery disease patients, not eligible for coronary artery bypass surgery, were recruited for the study. All patients received angiograms and were randomly assigned to either the lovastatin or placebo groups stratified by three baseline factors: sex, smoking status, and plasma cholesterol levels.

Patients initially received lovastatin 40mg twice a day or a matching placebo. Those patients receiving lovastatin whose total plasma cholesterol level was less than 110mg/dL at one visit or 120 mg/dL on two successive visits had their dosage halved, and were maintained on the optimal dosage for the remainder of the study. Coronary angiography was performed prior to screening and at month 24 (visit 18). Angiographic assessment of both femoral arteries was also performed at baseline and at month 24. Noninvasive ultrasound imaging of the carotid arteries (including carotid intima-media thickness) was performed every 6 months. Patients reported to the clinic monthly for 12 months, and at two-month intervals thereafter. Plasma lipids, routine laboratory safety and physical examinations were also performed.

Study Type

Interventional

Enrollment

270

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Howard N. Hodis, MD, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1985

Primary Completion (Actual)

February 1, 1992

Study Completion (Actual)

February 1, 1992

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 1, 2005

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0027
  • MK-803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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