JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

Detailed Description
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AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

Official Title
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A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein

Conditions
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Elevated High-sensitivity C-Reactive Protein (hsCRP)

Intervention / Treatment
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* Drug: Rosuvastatin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men 50 years or older, women 60 years or older Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL) Elevated levels of C-Reactive Protein (CRP) > 2.0 mg/L Exclusion Criteria: History of cardiovascular or cerebrovascular events Active liver disease Diabetes mellitus Uncontrolled hypertension or hypothyroidism History of certain malignancies Chronic inflammatory conditions History of alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>Rosuvastatin 20 mg once daily | Drug: Rosuvastatin<br>* Oral<br>* Other names: Crestor;|
| Placebo Comparator: Placebo<br>Placebo once daily | Other: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) | Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death Due to Any Cause | Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean | up to 5 years | 
| Time to Non-cardiovascular Death | Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean | up to 5 years | 
| Time to Development of Diabetes Mellitus | Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean | up to 5 years | 
| Time to Venous Thromboembolic Event | Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean | up to 5 years | 
| Time to Bone Fracture | Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary prevention, Cardiovascular disease, Statin therapy, C-reactive protein