Back to resultsDutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
Primary Purpose
Rosuvastatin, Heart Failure, Positron Emission Tomography (PET)
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Rosuvastatin
Positron emission tomography
Sponsored by
About this trial
This is an interventional treatment trial for Rosuvastatin
Eligibility Criteria
Inclusion Criteria: Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study. Exclusion Criteria: See above
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
To study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve). Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
Secondary Outcome Measures
To study the effect of rosuvastatin in Chronic Heart Failure on mismatch. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00228514
Brief Title
Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
Official Title
Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
At one site, patients participating in the Corona main study are asked to participate in the PET-substudy. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosuvastatin, Heart Failure, Positron Emission Tomography (PET)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Procedure
Intervention Name(s)
Positron emission tomography
Primary Outcome Measure Information:
Title
To study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve). Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
Secondary Outcome Measure Information:
Title
To study the effect of rosuvastatin in Chronic Heart Failure on mismatch. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.
Exclusion Criteria:
See above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca CV Medical Department
Organizational Affiliation
AstraZeneca BV
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
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