MARS - Monitored Atherosclerosis Regression Study

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00116870
First received: June 30, 2005
Last updated: December 9, 2009
Last verified: June 2005

June 30, 2005
December 9, 2009
June 1985
February 1992   (final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT00116870 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
MARS - Monitored Atherosclerosis Regression Study
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Atherosclerosis
  • Coronary Artery Disease
Drug: lovastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
February 1992
February 1992   (final data collection date for primary outcome measure)

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
Both
21 Years to 67 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116870
AG0027, MK-803
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
National Institute on Aging (NIA)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP