Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography
2 other identifiers
interventional
214
1 country
27
Brief Summary
The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2005
Typical duration for phase_4
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 15, 2011
CompletedAugust 31, 2011
August 1, 2011
3 years
May 22, 2006
March 17, 2011
August 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (\>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.
Baseline and 76 weeks
Secondary Outcomes (3)
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Baseline - 76Weeks
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Baseline - 76Weeks
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
Baseline - 76Weeks
Interventions
2.5-20 mg
3-hydroxy-3-methylglutaryl-coenzyme A
Eligibility Criteria
You may qualify if:
- Signed written informed consent,
- to 75 years old,
- Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)
You may not qualify if:
- Acute myocardial infarction within 72 hours after the onset,
- Heart failure of New York Heart Association (NYHA) Class III or above,
- Serious arrhythmia,
- Being treated with LDL-apheresis
- History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Shionogicollaborator
Study Sites (27)
Research Site
Gifu, Japan
Research Site
Hamada, Japan
Research Site
Hiroshima, Japan
Research Site
Ichinomiya, Japan
Research Site
Inba-mura, Japan
Research Site
Izumi, Japan
Research Site
Izumisano, Japan
Research Site
Izumo, Japan
Research Site
Kagoshima, Japan
Research Site
Kanazawa, Japan
Research Site
Kasuga, Japan
Research Site
Kobe, Japan
Research Site
Komaki, Japan
Research Site
Konancho, Japan
Research Site
Kumamoto, Japan
Research Site
Kurume, Japan
Research Site
Kyoto, Japan
Research Site
Osaka, Japan
Research Site
Ōmiya, Japan
Research Site
Sapporo, Japan
Research Site
Shinjō, Japan
Research Site
Shūnan, Japan
Research Site
Suita, Japan
Research Site
Tokyo, Japan
Research Site
Ube, Japan
Research Site
Yamaguchi, Japan
Research Site
Yokohama, Japan
Related Publications (1)
Daida H, Takayama T, Hiro T, Yamagishi M, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M; COSMOS Investigators. High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Cardiovasc Diabetol. 2012 Jul 25;11:87. doi: 10.1186/1475-2840-11-87.
PMID: 22831708DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Because there was no placebo arm the net effect of rosuvastatin was not clarified. This study examined only single measurable plaques, which might not represent pan-coronary nature of plaque.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Masunori Matsuzaki, MD
Yamaguchi University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
October 1, 2005
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
August 31, 2011
Results First Posted
July 15, 2011
Record last verified: 2011-08