Back to resultsEvaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease
Primary Purpose
Myocardial Ischaemia, Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Cholesterol lowering diet
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischaemia focused on measuring Crestor, Rosuvastatin, Cholesterol, Coronary artery disease, Myocardial ischaemia.
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Rosuvastatin
Diet
Outcomes
Primary Outcome Measures
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.
Secondary Outcome Measures
Change in duration of ischemic episodes
Safety
Several laboratory parameters as detailed in the protocol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00657527
Brief Title
Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia 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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischaemia, Coronary Artery Disease
Keywords
Crestor, Rosuvastatin, Cholesterol, Coronary artery disease, Myocardial ischaemia.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
2
Arm Type
No Intervention
Arm Description
Diet
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Behavioral
Intervention Name(s)
Cholesterol lowering diet
Primary Outcome Measure Information:
Title
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.
Time Frame
8 weekly
Secondary Outcome Measure Information:
Title
Change in duration of ischemic episodes
Time Frame
8 weekly
Title
Safety
Time Frame
8 weekly
Title
Several laboratory parameters as detailed in the protocol
Time Frame
8 weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Cressman, DO
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Russell Esterline
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease
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