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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657527

Enrollment

280

Registered

2008-04-14

Start date

2001-12-31

Completion date

2002-12-31

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Ischaemia

Keywords

Crestor, Rosuvastatin, Cholesterol, Coronary artery disease, Myocardial ischaemia.

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.

Interventions

DRUGRosuvastatin

BEHAVIORALCholesterol lowering diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.	8 weekly

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026