Skip to content

The Cholesterol and Recurrent Events trial

The Cholesterol and Recurrent Events trial - CARE

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012519
Enrollment
4000
Registered
2014-12-08
Start date
1989-12-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary heart disease

Interventions

Pravastatin group: Pravastatin 40mg as a once per day dose is administered. The average duration of follow-up will be more than 5 years. Placebo group: Matching placebo once daily is administered.

Sponsors

The CARE Investigators
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and postmenopausal women were eligible if they had had an acute myocardial infarction between 3 and 20 months and and had plasma total cholesterol levels of less than 240 mg per deciliter, LDL cholesterol levels of 115 to 174 mg per deciliter, and fasting triglyceride levels of less than 350 mg per deciliter.

Exclusion criteria

Exclusion criteria: Ejection fraction < 25%. Overt congestive heart failure (symptomatic despite drug therapy). Prior sensitivity to HMG-CoA reductase inhibitors. Nephrotic syndrome or other renal disease. Excessive ethanol intake as > 3 drinks per day. Hepatobiliary disease. Malignancy. History of immune disorders. Untreated and uncontrolled endocrine disease. Significant gastrointestinal disease. Treatment with other lipid-lowering drug. Severe valvular heart disease requiring surgery.

Design outcomes

Primary

MeasureTime frame
Death from coronary heart disease (including fatal myocardial infarction, either definite or probable; sudden death; death during a coronary intervention; and death from other coronary causes) or a symptomatic (unless during noncardiac surgery) nonfatal myocardial infarction confirmed by serum creatine kinase measurements.

Countries

North America

Contacts

Public ContactFrank M. Sacks

Harvard School of Public Health Department of Nutrition

fsacks@hsph.harvard.edu617-432-1420

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026