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
  Purpose

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 .


Condition Intervention Phase
Acute Anterior Myocardial Infarction
Drug: standard group
Drug: intensive group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard group
patients in this group received standard statin treatment: Atorvastatin statins 20mg / night .
Drug: standard group
standard statin treatment:Atorvastatin statins 20mg / night .
Other Name: 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 .
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936103

Contacts
Contact: Geng Wang, Dr +86-24-28897280 Wanggeng69@hotmail.com

Locations
China, Liaoning
Shenyang Northen Hospital Recruiting
Shenyang, Liaoning, China, 110016
Contact: Wang Geng, Dr    13309886393      
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Study Director: Geng Wang, Dr Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01936103     History of Changes
Other Study ID Numbers: NH-20120404
Study First Received: April 23, 2013
Last Updated: September 2, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
Acute anterior myocardial infarction
Percutaneous coronary stent implantation
Intensive statin therapy
Left ventricular function

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014