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Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study

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ClinicalTrials.gov Identifier: NCT00228514
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : November 15, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 27, 2005
First Posted Date  ICMJE September 29, 2005
Last Update Posted Date November 15, 2010
Study Start Date  ICMJE February 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)		 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 Emmission Tomography (PET-scan) is performed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)		 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2005)		 To study the effect of rosuvastatin in Chronic Heart Failure on mismatch. Before and 6 months after study medication is started a Positron Emmission Tomography (PET-scan) is performed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
Official Title  ICMJE Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Rosuvastatin
  • Heart Failure
  • Positron Emission Tomography (PET)
Intervention  ICMJE
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Procedure: Positron emission tomography
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 27, 2005)		 40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228514
Other Study ID Numbers  ICMJE 4522IL/0098 Dutch SubStudy
D3562C00098
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca CV Medical Department AstraZeneca BV
PRS Account AstraZeneca
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP