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Effects of Intensive Statin Treatment on Left Ventricular Function

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ClinicalTrials.gov Identifier: NCT01936103
Recruitment Status : Unknown
Verified August 2013 by Han Yaling, MD, Shenyang Northern Hospital.
Recruitment status was:  Recruiting
First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):

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 .

Condition or disease Intervention/treatment Phase
Acute Anterior Myocardial Infarction Drug: standard group Drug: intensive group Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : April 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. left ventricular function [ Time Frame: 30 days ]
    ultrasonic observation of left ventricular end-diastolic diameter

  2. left ventricular function [ Time Frame: 30 days ]
    ultrasonic observation of left ventricular end-systolic volume

  3. left ventricular function [ Time Frame: 30 days ]
    ultrasonic observation of left ventricular fractional shortening RWSI

  4. left ventricular function [ Time Frame: 30 days ]
    ultrasonic observation of the left ventricular ejection fraction

  5. left ventricular function [ Time Frame: 30 days ]
    ultrasonic observation of E/A


Secondary Outcome Measures :
  1. the left ventricular function [ Time Frame: 6 months ]
  2. the left ventricular function [ Time Frame: 1 year ]
  3. plasma brain natriuretic peptide [ Time Frame: 30days ]
  4. plasma brain natriuretic peptide [ Time Frame: 6 months ]
  5. plasma brain natriuretic peptide [ Time Frame: 1 year ]

Other Outcome Measures:
  1. enzymes [ Time Frame: 1 year ]
    the level of CK peak

  2. 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 .

  3. Aspartate aminotransferase (AST) [ Time Frame: 1 year ]
    Aspartate aminotransferase (AST) returned to normal in the perioperative period

  4. enzymes [ Time Frame: 1 year ]
    CK-MB peak

  5. enzymes [ Time Frame: 1 year ]
    troponin (TnT)

  6. enzymes [ Time Frame: 1 year ]
    CK-MB peak time

  7. Aspartate aminotransferase (AST) [ Time Frame: 1 year ]
    any elevation> 3 times the proportion

  8. alanine aminotransferase (ALT) [ Time Frame: 1 year ]
    alanine aminotransferase (ALT)returned to normal in the perioperative period

  9. alanine aminotransferase (ALT) [ Time Frame: 1 year ]
    any elevation> 3 times the proportion


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01936103     History of Changes
Other Study ID Numbers: NH-20120404
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: August 2013

Keywords provided by Han Yaling, MD, 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 Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors