Data

The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) dataset

University of Sydney

Dataset description

This dataset includes 9,014 participants receiving either pravastatin, 40 mg/day or placebo, with a total cholesterol level at baseline of 4.0 to 7.0 mmol/L (155 to 270 mg/dl) and with a history of acute myocardial infarction or hospitalization for unstable angina pectoris. Baseline data will include demographics, qualifying event (myocardial infarction or unstable angina), coronary heart disease risk factors (smoking status, history of hypertension, diabetes mellitus and obesity), history of other vascular diseases, revascularization, medication use and lipid concentrations (total cholesterol, LDL-c, HDL-c and triglycerides). Clinical outcomes will include overall survival and cause of death over a 6-year and 16-year follow-up period.
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Source Study

Trial acronym

LIPID

Trial ID

ACTRN12616000535471

Purpose

Prevention

Phase

Phase 3

Funding

Charities/Societies/Foundations,National Heart Foundation of Australia

Scientific enquiries

Prof John Simes

Brief Summary

This multicentre, double-blind, placebo-controlled clinical trial is designed to determine whether prolonged reduction in blood cholesterol with pravastatin, one of the class of 3-hydroxy-3-methylglutaryl-coenzyme-A reductase (HMG-CoA reductase) inhibitors, will reduce mortality from coronary heart disease in patients with a history of myocardial infarction or unstable angina pectoris. To qualify for entry, a patient must have a blood cholesterol level in the range 4.0 to 7.0 mmol/L, and must ha ....
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Key Inclusion Criteria

1. ENTRY DIAGNOSIS: A. Patients who have suffered an acute myocardial infarction in the period three months to three years prior to screening, where acute myocardial infarction satisfies the following criteria: 1) Discharge diagnosis of acute myocardial infarction in hospital records, OR 2) Any 2 of the following 3: a. History of typical ischaemic pain lasting for at least 15 minutes and unresponsive to sublingual nitrates b. Elevation of CK enzymes to more than twice the upper limit of normal c ....
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Key Exclusion Criteria

1. Patients who are unlikely to be available for the duration of follow-up: i) patients with life threatening illnesses other than coronary artery disease, who are not expected to survive for six years (such as organ transplants), or ii) those who are unreliable including those with known drug or alcohol related problems. 2. Any cardiac surgery, angioplasty, major surgery or major illness within the past three months. 3. Severely compromised cardiac function (whether due to ischaemic heart disea ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    9014

Min. age    31 Years

Max. age    75 Years

Sex    Both males and females

Condition category    Coronary heart disease

Condition code    Cardiovascular

Intervention

Intervention code Treatment: Drugs

20mg pravastatin oral tablet twice daily for 6 years. Dosage will be halved if total cholesterol falls below 3.0 mmol/L on two successive follow-up visits. Compliance will be assessed by site staff at follow up visits and subjects encouraged to take tablets as directed.

Comparison

Control group Placebo

Matching placebo, microcellulose tablet

Outcomes

Outcome: Mortality due to coronary heart disease. Assessed by submission of death certificate and hospital case notes for adjudication by an Outcomes Committee.
Timepoint: 6 years. Subsequent assessment by periodic linkage with central death registries to 16 years

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au