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

Condition(s) targeted: Myocardial Ischaemia; Coronary Artery Disease

Intervention: Rosuvastatin (Drug); Cholesterol lowering diet (Behavioral)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael Cressman, DO, Study Director, Affiliation: AstraZeneca
Russell Esterline, Study Chair, Affiliation: AstraZeneca

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.

Official title: An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.

Secondary outcome:

Change in duration of ischemic episodes

Safety

Several laboratory parameters as detailed in the protocol

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: December 2001
Ending date: March 2003
Last updated: April 8, 2008