Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

NCT ID: NCT00728988

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-04-30

Brief Summary

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This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atorvastatin Group

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.

Usual Care Group

Group Type OTHER

Atorvastatin

Intervention Type DRUG

40mg daily after PCI for 30 days.

Interventions

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Atorvastatin

80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.

Intervention Type DRUG

Atorvastatin

40mg daily after PCI for 30 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-ST elevated ACS; LDL-C \> 80 mg/dl

Exclusion Criteria

* ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Guangzhou, Guangdong, China

Site Status

Pfizer Investigational Site

Changsha, Hunan, China

Site Status

Pfizer Investigational Site

Shenyang, Liaoning, China

Site Status

Pfizer Investigational Site

Shenyang, Liaoning, China

Site Status

Pfizer Investigational Site

Qingdao, Shandong, China

Site Status

Pfizer Investigational Site

Hangzhou, Zhejiang, China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Seongnam-si, Gyeonggi-do, Korea, South Korea

Site Status

Pfizer Investigational Site

Busan, , South Korea

Site Status

Pfizer Investigational Site

Daegu, , South Korea

Site Status

Pfizer Investigational Site

Daegu, , South Korea

Site Status

Pfizer Investigational Site

Daegu, , South Korea

Site Status

Pfizer Investigational Site

Daejeon, , South Korea

Site Status

Pfizer Investigational Site

Gangneung-si, Gangwon-do, , South Korea

Site Status

Pfizer Investigational Site

Gwangju, , South Korea

Site Status

Pfizer Investigational Site

Jinju-si, Gyeongsangnam-do, , South Korea

Site Status

Pfizer Investigational Site

Koyang-shi, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Ulsan, , South Korea

Site Status

Countries

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China South Korea

References

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Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.

Reference Type DERIVED
PMID: 24216317 (View on PubMed)

Related Links

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Other Identifiers

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A2581161

Identifier Type: -

Identifier Source: org_study_id

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