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

Phase 3

Completed

• Conditions: Myocardial Ischaemia; Coronary Artery Disease
• Interventions: Drug: Rosuvastatin; Behavioral: Cholesterol lowering diet

• Registration Number: NCT00657527
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study Completion: 2002-12
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	Rosuvastatin
2	Cholesterol lowering diet	Diet

Primary Outcome Measures

Name	Time	Method
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.	8 weekly

Secondary Outcome Measures

Name	Time	Method
Change in duration of ischemic episodes	8 weekly
Safety	8 weekly
Several laboratory parameters as detailed in the protocol	8 weekly