Effects of Intensive Statin Treatment on Left Ventricular Function

September 2, 2013 updated by: Han Yaling, MD, Shenyang Northern Hospital

Effects of Intensive Statin Therapy on Left Ventricular Function for Patients With the First Acute Anterior Myocardial Infarction After Directly to Percutaneous Coronary Intervention.

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 .

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • Shenyang Northen Hospital
        • Contact:
          • Wang Geng, Dr
          • Phone Number: 13309886393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: standard group
patients in this group received standard statin treatment: Atorvastatin statins 20mg / night .
standard statin treatment:Atorvastatin statins 20mg / night .
Other Names:
  • Lipitor
EXPERIMENTAL: 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 .
intensive statin treatment: Admission atorvastatin statins the 80mg, after surgery,atorvastatin 40mg / night,and until 30 days after the operation
Other Names:
  • intensive Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular function
Time Frame: 30 days
ultrasonic observation of left ventricular end-diastolic diameter
30 days
left ventricular function
Time Frame: 30 days
ultrasonic observation of left ventricular end-systolic volume
30 days
left ventricular function
Time Frame: 30 days
ultrasonic observation of left ventricular fractional shortening RWSI
30 days
left ventricular function
Time Frame: 30 days
ultrasonic observation of the left ventricular ejection fraction
30 days
left ventricular function
Time Frame: 30 days
ultrasonic observation of E/A
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
the left ventricular function
Time Frame: 6 months
6 months
the left ventricular function
Time Frame: 1 year
1 year
plasma brain natriuretic peptide
Time Frame: 30days
30days
plasma brain natriuretic peptide
Time Frame: 6 months
6 months
plasma brain natriuretic peptide
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
enzymes
Time Frame: 1 year
the level of CK peak
1 year
Major adverse cardiac and cerebral events at 1 year
Time Frame: 1 year
1 year after death, cardiac death , myocardial infarction , heart failure , cardiac causes hospitalization , revascularization combined endpoint of cerebrovascular events .
1 year
Aspartate aminotransferase (AST)
Time Frame: 1 year
Aspartate aminotransferase (AST) returned to normal in the perioperative period
1 year
enzymes
Time Frame: 1 year
CK-MB peak
1 year
enzymes
Time Frame: 1 year
troponin (TnT)
1 year
enzymes
Time Frame: 1 year
CK-MB peak time
1 year
Aspartate aminotransferase (AST)
Time Frame: 1 year
any elevation> 3 times the proportion
1 year
alanine aminotransferase (ALT)
Time Frame: 1 year
alanine aminotransferase (ALT)returned to normal in the perioperative period
1 year
alanine aminotransferase (ALT)
Time Frame: 1 year
any elevation> 3 times the proportion
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Geng Wang, Dr, Shenyang Northern Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (ESTIMATE)

September 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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