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Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

NCT ID: NCT01033058

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-06-30

Brief Summary

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This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Detailed Description

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ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization;

This study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Conditions

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STEMI

Keywords

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STEMI atorvastatin PCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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usual care

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI

intensive statin treatment

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI

Interventions

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atorvastatin

80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI

Intervention Type DRUG

atorvastatin

No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI

Intervention Type DRUG

Other Intervention Names

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Lipitor Lipitor

Eligibility Criteria

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Inclusion Criteria

* 20-75 years old
* myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment.
* ECG showed elevated ST segment in 3 or more contiguous leads
* diagnosed with acute STEMI
* eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment

Exclusion Criteria

* allergic or experienced serious adverse reaction to HMG-CoA reductase
* pregnancy, lactation, or child bearing potential women without any effective contraception
* accompanied with malignant disease
* active hepatic disease or hepatic dysfunction
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing Chaoyang Hospital

Principal Investigators

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Xinchun Yang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Beijing Chaoyang Hospital, China

Locations

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Chaoyang Hospital

Beijing, Chaoyang, China

Site Status

Countries

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China

Central Contacts

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Xinchun Yang, Prof.

Role: CONTACT

Phone: +86 10 85231937

Email: [email protected]

Facility Contacts

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Yanying Shen, Dr.

Role: primary

Other Identifiers

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CHN2009CV005

Identifier Type: -

Identifier Source: org_study_id