Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

NCT ID: NCT01372839

Last Updated: 2011-06-14

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

Detailed Description

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

Conditions

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Myocardial Infarction Unstable Angina

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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Atorvastatin

80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Usual care

statin dose should not be higher than that described in exclusion criteria.

Group Type OTHER

Statin

Intervention Type DRUG

Usual care, but statin dose should not be higher than that described in exclusion criteria

Interventions

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Atorvastatin

Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Intervention Type DRUG

Statin

Usual care, but statin dose should not be higher than that described in exclusion criteria

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-85 years old
* Patients with clinical diagnosis of ACS
* Evidence of a personally signed and dated informed consent document

Exclusion Criteria

* Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
* LDL-C \< 1.8mmol/L in patients without statin therapy in 1 months
* Endstage congestive heart failure, or LVEF \< 30%
* Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL
* Myopathy or increased creatine kinase (CK\>2 UNL)
* Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L)
* Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
* Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
* Pregnancy, lactation, or child bearing potential women without any effective contraception
* Accompanied with malignant disease or other disease, which cause life expectancy \< 6 months
* Participating in other interventional clinical trails using drugs or devices
* Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Cardiology of Xijing Hospital; Fourth Military Medical University

Principal Investigators

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Yong Huo, MD

Role: STUDY_DIRECTOR

Division of Cardiology, Peking University First Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ling Tao, M.D Ph.D

Role: CONTACT

+86-15002955798

Facility Contacts

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Ling Tao, M.D Ph.D

Role: primary

+86-15002955798

Other Identifiers

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xj050511

Identifier Type: -

Identifier Source: org_study_id

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