Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients

NCT ID: NCT01040936

Last Updated: 2011-06-15

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

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

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PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.

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

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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conventional group

patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year

intensive group

patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

patients admitted with Non-ST elevation ACS will be loaded with atorvastatin 80mg once, continued with 40mg/d for 30d, then change to 20mg/d, as a regular dose in China

Interventions

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Atorvastatin

patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year

Intervention Type DRUG

Atorvastatin

patients admitted with Non-ST elevation ACS will be loaded with atorvastatin 80mg once, continued with 40mg/d for 30d, then change to 20mg/d, as a regular dose in China

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* finish informed consent
* age≥18y and under 75y
* diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
* willing to receive the coronary angiography and potential PCI therapy

Exclusion Criteria

* patient was treated by statins before randomization
* stable angina or ST elevation myocardial infarction
* without informed consent
* abnormal liver function before randomization, (AST,ALT≥3ULN)
* active hepatitis or muscular disease
* impaired renal function with serum creatinine level \> 3mg/dl
* impaired left ventricular systolic function with LVEF\< 30%
* participating in other studies
* non-PCI treated patients after coronary angiography will be washed out
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Jiao Tong University

Principal Investigators

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Wei Feng Shen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Ruijin Hospital, Dept. of Cardiology

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi Zhang, MD

Role: CONTACT

+862164370045 ext. 665380

Xin Chen, MD

Role: CONTACT

+862164370045 ext. 665215

Facility Contacts

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Xin Chen, MD

Role: primary

+862164370045 ext. 665215

Other Identifiers

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RJH-2009

Identifier Type: OTHER

Identifier Source: secondary_id

RJH-091228

Identifier Type: -

Identifier Source: org_study_id

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