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Effects of Intensive Statin Treatment on Left Ventricular Function

NCT ID: NCT01936103

Last Updated: 2013-09-05

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-07-31

Brief Summary

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First acute anterior myocardial infarction in patients with primary PCI preoperative and postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional -dose therapy , patients can improve left ventricular function , reduce major adverse cardiovascular events .

Detailed Description

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Conditions

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Acute Anterior Myocardial Infarction

Keywords

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Acute anterior myocardial infarction Percutaneous coronary stent implantation Intensive statin therapy Left ventricular function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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standard group

patients in this group received standard statin treatment： Atorvastatin statins 20mg / night .

Group Type ACTIVE_COMPARATOR

standard group

Intervention Type DRUG

standard statin treatment:Atorvastatin statins 20mg / night .

intensive group

patients in this group received intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation , and thereafter 20mg / night .

Group Type EXPERIMENTAL

intensive group

Intervention Type DRUG

intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation

Interventions

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standard group

standard statin treatment:Atorvastatin statins 20mg / night .

Intervention Type DRUG

intensive group

intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation

Intervention Type DRUG

Other Intervention Names

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Lipitor intensive Lipitor

Eligibility Criteria

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Inclusion Criteria

1. ≥ 18 years of age
2. the first time clinical diagnosis of acute anterior myocardial infarction , the time of onset ≤ 12 hours ,intends underwent emergency PCI
3. informed consent

Exclusion Criteria

1. Taking , or the need for long-term use of statins is greater than the initial dose
2. treated with PCI again within a mouth
3. active liver disease or liver dysfunction
4. the diagnosis of myopathy
5. severe renal insufficiency ( serum creatinine \> 178umol / L )
6. Statin drug allergy or had a serious adverse reaction
7. severe aortic stenosis or mitral stenosis , hypertrophic obstructive cardiomyopathy , pericardial disease
8. pregnancy
9. malignancy or any other end-stage diseases result in a life expectancy of \< 6 months
10. be participating in other clinical studies
11. not suitable for inclusion of the other cases
12. not treated with PCI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Northern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Yaling, MD

vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geng Wang, Dr

Role: STUDY_DIRECTOR

Shenyang Northern Hospital

Locations

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Shenyang Northen Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Geng Wang, Dr

Role: CONTACT

Phone: +86-24-28897280

Email: [email protected]

Facility Contacts

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Wang Geng, Dr

Role: primary

Other Identifiers

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NH-20120404

Identifier Type: -

Identifier Source: org_study_id