Completed

NHLBI Type II Coronary Intervention Study

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What is being tested

cholestyramine

Drug
Who is being recruted

Hyperlipidemias+19

+ Hyperlipoproteinemias

+ Infarction

From 21 to 55 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: November 1971
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: April 27, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1971

Actual date on which the first participant was enrolled.

BACKGROUND: There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. It should be noted that patients in the CPPT did not have known preexisting coronary heart disease. DESIGN NARRATIVE: A randomized, double-blind trial, with single experimental and control groups. The experimental group received drug therapy (cholestyramine); the control group received placebo. Both groups received diet therapy. The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. Patients were followed under therapy for at least 5 years.

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: April 27, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasHyperlipoproteinemiasInfarctionIschemiaLipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsNecrosisCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesGenetic Diseases, InbornDyslipidemiasLipid Metabolism DisordersCardiovascular DiseasesCoronary DiseaseHeart DiseasesHyperlipoproteinemia Type IIMyocardial InfarctionMyocardial Ischemia

Criteria

Men and women with angiographically demonstrated coronary artery disease.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers