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Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

NCT ID: NCT00329160

Last Updated: 2011-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hypercholesteremia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosuvastatin

2.5-20 mg

Intervention Type DRUG

HMG CoA inhibitor

3-hydroxy-3-methylglutaryl-coenzyme A

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Masunori Matsuzaki, MD

Role: PRINCIPAL_INVESTIGATOR

Yamaguchi University Hospital

Locations

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Research Site

Gifu, , Japan

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Hamada, , Japan

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Hiroshima, , Japan

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Ichinomiya, , Japan

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Inba-mura, , Japan

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Izumi, , Japan

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Izumisano, , Japan

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Izumo, , Japan

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Kagoshima, , Japan

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Kanazawa, , Japan

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Kasuga, , Japan

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Kobe, , Japan

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Komaki, , Japan

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Konancho, , Japan

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Kumamoto, , Japan

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Kurume, , Japan

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Kyoto, , Japan

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Osaka, , Japan

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Ōmiya, , Japan

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Sapporo, , Japan

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Shinjō, , Japan

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Shūnan, , Japan

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Suita, , Japan

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Tokyo, , Japan

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Ube, , Japan

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Yamaguchi, , Japan

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Yokohama, , Japan

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Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22831708 (View on PubMed)

Other Identifiers

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0407E1841

Identifier Type: -

Identifier Source: secondary_id

D3565L00002

Identifier Type: -

Identifier Source: org_study_id