Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction

NCT ID: NCT01997294

Last Updated: 2016-10-11

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

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-02-28

Brief Summary

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Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sequential therapy group

80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year

Group Type ACTIVE_COMPARATOR

Sequential therapy of atorvastatin

Intervention Type DRUG

80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI

Usual Therapy of atorvastatin

20mg/d before and after PPCI for 1 year

Group Type PLACEBO_COMPARATOR

Sequential therapy of atorvastatin

Intervention Type DRUG

80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI

Interventions

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Sequential therapy of atorvastatin

80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sighed informed consent
* Diagnosised as acute myocardial infarction
* Time frame less than 12 hours since the occurance of chest pain
* Aggred to receive sirolimus-eluted coronary stents
* Patients willing to accepte follow-up

Exclusion Criteria

* Allegy to statins or with a history against statin therapy
* Allegy to any products that will be used during PPCI
* Disagreed to receive PPCI and other related therapy
* Existing sever liver dysfuntion that statins can not be used according to the guildlines
* Sever kidney dysfunction (creatinine \>3mg/dl or eGFR\<30ml/min)
* Sever left ventricular dysfunction (Killip grade 3)
* Patients are currently taking medicine that may influence the use of statin
* Patients with a history of alcohol abuse or durg abuse
* Woman during pregnancy or lactation
* Patients who has attended other clinical trials
* Patients who has received PCI or CABG previously
* Patients who can not agree to accept study protocol
* Other conditions that may not sutible for the current study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhang Qi, MD

OTHER

Sponsor Role lead

Responsible Party

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Zhang Qi, MD

Visa Chief of Department of Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Weifeng Shen, MD. PhD.

Role: STUDY_DIRECTOR

Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University

Locations

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Ruijin Hospital, Dept. of Cardiology

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2011BAI11B05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RJH20130115

Identifier Type: -

Identifier Source: org_study_id

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