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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657527
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : March 16, 2009
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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.

Condition or disease Intervention/treatment Phase
Myocardial Ischaemia Coronary Artery Disease Drug: Rosuvastatin Behavioral: Cholesterol lowering diet Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2001
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Rosuvastatin
Other Name: Crestor

No Intervention: 2
Behavioral: Cholesterol lowering diet

Primary Outcome Measures :
  1. Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring. [ Time Frame: 8 weekly ]

Secondary Outcome Measures :
  1. Change in duration of ischemic episodes [ Time Frame: 8 weekly ]
  2. Safety [ Time Frame: 8 weekly ]
  3. Several laboratory parameters as detailed in the protocol [ Time Frame: 8 weekly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657527

Sponsors and Collaborators
Study Director: Michael Cressman, DO AstraZeneca
Study Chair: Russell Esterline AstraZeneca

Responsible Party: Elisabeth Björk, AstraZeneca Identifier: NCT00657527     History of Changes
Other Study ID Numbers: 4522IL/0043
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Coronary artery disease
Myocardial ischaemia.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors