Clinical trial NCT00329160: Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesteremia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
First posted: 2006-05-24
Enrollment: 214
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent,
* 20 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
timeFrame: Baseline and 76 weeks
Secondary outcomes:
measure: Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
timeFrame: Baseline - 76Weeks
measure: Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
timeFrame: Baseline - 76Weeks
measure: Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
timeFrame: Baseline - 76Weeks
Other outcomes:
Locations:
city: Gifu
country: Japan
facility: Research Site
city: Hamada
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Ichinomiya
country: Japan
facility: Research Site
city: Inba-mura
country: Japan
facility: Research Site
city: Izumisano
country: Japan
facility: Research Site
city: Izumi
country: Japan
facility: Research Site
city: Izumo
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanazawa
country: Japan
facility: Research Site
city: Kasuga
country: Japan
facility: Research Site
city: Kobe
country: Japan
facility: Research Site
city: Komaki
country: Japan
facility: Research Site
city: Konan-cho
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kurume
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Omiya
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Shinjo
country: Japan
facility: Research Site
city: Shunan
country: Japan
facility: Research Site
city: Suita
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Ube
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yokohama
country: Japan
facility: Research Site
Study officials:
affiliation: Yamaguchi University Hospital
name: Masunori Matsuzaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.