ong Term Intervention with Pravastatin in Ischaemic Disease

Phase 3

Completed

• Conditions: Coronary heart disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12616000535471
• Lead Sponsor: HMRC Clinical Trials Centre, The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9000

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

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 disease or not), manifest by either:
i)New York Heart Association (NYHA) Class III or IV congestive heart failure (at the time of assessment).
ii)Left ventricular ejection fraction less than 25% (if measured).

4. History of cerebrovascular disease, including completed stroke or transient ischaemic attack within three months.

5. Significant renal or hepatic disease (such as serum creatinine > 160 micromol/L, serum albumin <3.0 g/dl; bilirubin >30 micromol/L, serum ALT or AST >1.5x the upper limit of normal).

6. Any uncontrolled endocrine disease (particularly if likely to require hospitalisation); chronic pancreatitis; dysproteinaemia; porphyria; systemic lupus erythematosus.

7. Treatment with :
(a) other lipid-lowering agents;
(b) cyclosporin;
(c) other investigational drugs.

8. Known hypersensitivity to HMG-CoA reductase inhibitors or serious adverse reactions from prior administration of HMG-CoA reductase inhibitors.

9. Significant gastrointestinal disease or surgery which might interfere with drug absorption.

10. Women of child-bearing potential (ie pre-menopausal, unless surgically sterilised) and lactating women.

11. Fasting triglyceride (as measured by the Central Lipid Laboratory) of greater than 5mmol/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified