search
Back to results

Effects of Intensive Statin Treatment on Left Ventricular Function

Primary Purpose

Acute Anterior Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
standard group
intensive group
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Anterior Myocardial Infarction focused on measuring Acute anterior myocardial infarction, Percutaneous coronary stent implantation, Intensive statin therapy, Left ventricular function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shenyang Northen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard group

intensive group

Arm Description

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

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 .

Outcomes

Primary Outcome Measures

left ventricular function
ultrasonic observation of left ventricular end-diastolic diameter
left ventricular function
ultrasonic observation of left ventricular end-systolic volume
left ventricular function
ultrasonic observation of left ventricular fractional shortening RWSI
left ventricular function
ultrasonic observation of the left ventricular ejection fraction
left ventricular function
ultrasonic observation of E/A

Secondary Outcome Measures

the left ventricular function
the left ventricular function
plasma brain natriuretic peptide
plasma brain natriuretic peptide
plasma brain natriuretic peptide

Full Information

First Posted
April 23, 2013
Last Updated
September 2, 2013
Sponsor
Shenyang Northern Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01936103
Brief Title
Effects of Intensive Statin Treatment on Left Ventricular Function
Official Title
Effects of Intensive Statin Therapy on Left Ventricular Function for Patients With the First Acute Anterior Myocardial Infarction After Directly to Percutaneous Coronary Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Anterior Myocardial Infarction
Keywords
Acute anterior myocardial infarction, Percutaneous coronary stent implantation, Intensive statin therapy, Left ventricular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard group
Arm Type
Active Comparator
Arm Description
patients in this group received standard statin treatment： Atorvastatin statins 20mg / night .
Arm Title
intensive group
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
standard group
Other Intervention Name(s)
Lipitor
Intervention Description
standard statin treatment:Atorvastatin statins 20mg / night .
Intervention Type
Drug
Intervention Name(s)
intensive group
Other Intervention Name(s)
intensive Lipitor
Intervention Description
intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation
Primary Outcome Measure Information:
Title
left ventricular function
Description
ultrasonic observation of left ventricular end-diastolic diameter
Time Frame
30 days
Title
left ventricular function
Description
ultrasonic observation of left ventricular end-systolic volume
Time Frame
30 days
Title
left ventricular function
Description
ultrasonic observation of left ventricular fractional shortening RWSI
Time Frame
30 days
Title
left ventricular function
Description
ultrasonic observation of the left ventricular ejection fraction
Time Frame
30 days
Title
left ventricular function
Description
ultrasonic observation of E/A
Time Frame
30 days
Secondary Outcome Measure Information:
Title
the left ventricular function
Time Frame
6 months
Title
the left ventricular function
Time Frame
1 year
Title
plasma brain natriuretic peptide
Time Frame
30days
Title
plasma brain natriuretic peptide
Time Frame
6 months
Title
plasma brain natriuretic peptide
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
enzymes
Description
the level of CK peak
Time Frame
1 year
Title
Major adverse cardiac and cerebral events at 1 year
Description
1 year after death, cardiac death , myocardial infarction , heart failure , cardiac causes hospitalization , revascularization combined endpoint of cerebrovascular events .
Time Frame
1 year
Title
Aspartate aminotransferase (AST)
Description
Aspartate aminotransferase (AST) returned to normal in the perioperative period
Time Frame
1 year
Title
enzymes
Description
CK-MB peak
Time Frame
1 year
Title
enzymes
Description
troponin (TnT)
Time Frame
1 year
Title
enzymes
Description
CK-MB peak time
Time Frame
1 year
Title
Aspartate aminotransferase (AST)
Description
any elevation> 3 times the proportion
Time Frame
1 year
Title
alanine aminotransferase (ALT)
Description
alanine aminotransferase (ALT)returned to normal in the perioperative period
Time Frame
1 year
Title
alanine aminotransferase (ALT)
Description
any elevation> 3 times the proportion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age the first time clinical diagnosis of acute anterior myocardial infarction , the time of onset ≤ 12 hours ,intends underwent emergency PCI informed consent Exclusion Criteria: Taking , or the need for long-term use of statins is greater than the initial dose treated with PCI again within a mouth active liver disease or liver dysfunction the diagnosis of myopathy severe renal insufficiency ( serum creatinine > 178umol / L ) Statin drug allergy or had a serious adverse reaction severe aortic stenosis or mitral stenosis , hypertrophic obstructive cardiomyopathy , pericardial disease pregnancy malignancy or any other end-stage diseases result in a life expectancy of < 6 months be participating in other clinical studies not suitable for inclusion of the other cases not treated with PCI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geng Wang, Dr
Phone
+86-24-28897280
Email
Wanggeng69@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geng Wang, Dr
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shenyang Northen Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Geng, Dr
Phone
13309886393

12. IPD Sharing Statement

Learn more about this trial

Effects of Intensive Statin Treatment on Left Ventricular Function

We'll reach out to this number within 24 hrs