Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Myocardial Ischaemia

Treatments: Behavioral: Cholesterol lowering diet; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00657527

D3560C00043

4522IL/0043

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of Coronary arterial disease
• Suffering ischaemic episodes/exercise induced ischaemia
• Not taking any cholesterol lowering medication

Exclusion criteria

• Unstable angina or heart attack less than one month before trial entry
• Coronary arterial surgery as defined by protocol
• Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

2

No Intervention group

Description:

Diet

Treatment:

Behavioral: Cholesterol lowering diet