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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Related Study

Long Term Intervention with Pravastatin in Ischaemic Disease

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 have suffered a myocardial infarction or have been admitted to hospital with unstable angina, within three months to three years prior to screening. The primary study outcome will be death due to coronary heart disease. Secondary analyses will be of death from all causes, combined incidence of non fatal myocardial infarction and fatal coronary heart disease, stroke (total and non-haemorrhagic), cardiovascular mortality, coronary revascularisation (CABG and coronary angioplasty), and number of days in hospital during the follow-up period. The goal of intervention is to reduce total blood cholesterol by an average of 25% in patients allocated pravastatin compared with those allocated placebo. To detect reliably the expected effect of such a cholesterol difference on the primary endpoint requires about 9,000 patients be randomised in equal numbers to pravastatin or placebo, and that follow-up of these patients continues for a minimum 5 years for each surviving patient.

Conditions

Condition Codes

Intervention Code

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. Development of new Q-Waves and/or evolutionary ST-T wave changes lasting at least one day. OR B. Patients who have been discharged from hospital with a diagnosis of unstable angina pectoris three months to three years prior to assessment, where unstable angina pectoris is defined as definite ischaemic pain increasing in frequency and duration, and/or angina occurring at rest. 2. SERUM CHOLESTEROL: Total cholesterol between 4.0 and 7.0 mmol/L, measured by the Central Lipid Laboratory in the 4 weeks prior to randomisation

Study Type

  • Interventional

Ethics Approval

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