Effects of Intensive Statin Treatment on Left Ventricular Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Shenyang Northern Hospital
Sponsor:
Information provided by (Responsible Party):
Han Yaling, MD, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01936103
First received: April 23, 2013
Last updated: September 2, 2013
Last verified: August 2013

April 23, 2013
September 2, 2013
April 2012
May 2014   (final data collection date for primary outcome measure)
  • left ventricular function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ultrasonic observation of left ventricular end-diastolic diameter
  • left ventricular function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ultrasonic observation of left ventricular end-systolic volume
  • left ventricular function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ultrasonic observation of left ventricular fractional shortening RWSI
  • left ventricular function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ultrasonic observation of the left ventricular ejection fraction
  • left ventricular function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ultrasonic observation of E/A
Same as current
Complete list of historical versions of study NCT01936103 on ClinicalTrials.gov Archive Site
  • the left ventricular function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • the left ventricular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • plasma brain natriuretic peptide [ Time Frame: 30days ] [ Designated as safety issue: No ]
  • plasma brain natriuretic peptide [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • plasma brain natriuretic peptide [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
  • enzymes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the level of CK peak
  • Major adverse cardiac and cerebral events at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1 year after death, cardiac death , myocardial infarction , heart failure , cardiac causes hospitalization , revascularization combined endpoint of cerebrovascular events .
  • Aspartate aminotransferase (AST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Aspartate aminotransferase (AST) returned to normal in the perioperative period
  • enzymes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    CK-MB peak
  • enzymes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    troponin (TnT)
  • enzymes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    CK-MB peak time
  • Aspartate aminotransferase (AST) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    any elevation> 3 times the proportion
  • alanine aminotransferase (ALT) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    alanine aminotransferase (ALT)returned to normal in the perioperative period
  • alanine aminotransferase (ALT) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    any elevation> 3 times the proportion
Same as current
 
Effects of Intensive Statin Treatment on Left Ventricular Function
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 .

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Anterior Myocardial Infarction
  • Drug: standard group
    standard statin treatment:Atorvastatin statins 20mg / night .
    Other Name: Lipitor
  • Drug: intensive group
    intensive statin treatment: Admission atorvastatin statins the 80mg, after surgery,atorvastatin 40mg / night,and until 30 days after the operation
    Other Name: intensive Lipitor
  • Active Comparator: standard group
    patients in this group received standard statin treatment: Atorvastatin statins 20mg / night .
    Intervention: Drug: standard group
  • 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 .
    Intervention: Drug: intensive group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Geng Wang, Dr +86-24-28897280 Wanggeng69@hotmail.com
China
 
NCT01936103
NH-20120404
No
Han Yaling, MD, Shenyang Northern Hospital
Shenyang Northern Hospital
Not Provided
Study Director: Geng Wang, Dr Shenyang Northern Hospital
Shenyang Northern Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP