Clinical trial NCT01936103: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Anterior Myocardial Infarction
Keywords: Acute anterior myocardial infarction
Percutaneous coronary stent implantation
Intensive statin therapy
Left ventricular function
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility 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

Primary outcomes:
measure: left ventricular function
timeFrame: 30 days
measure: left ventricular function
timeFrame: 30 days
measure: left ventricular function
timeFrame: 30 days
measure: left ventricular function
timeFrame: 30 days
measure: left ventricular function
timeFrame: 30 days
Secondary outcomes:
measure: the left ventricular function
timeFrame: 6 months
measure: the left ventricular function
timeFrame: 1 year
measure: plasma brain natriuretic peptide
timeFrame: 30days
measure: plasma brain natriuretic peptide
timeFrame: 6 months
measure: plasma brain natriuretic peptide
timeFrame: 1 year
Other outcomes:
measure: enzymes
timeFrame: 1 year
measure: Major adverse cardiac and cerebral events at 1 year
timeFrame: 1 year
measure: Aspartate aminotransferase (AST)
timeFrame: 1 year
measure: enzymes
timeFrame: 1 year
measure: enzymes
timeFrame: 1 year
measure: enzymes
timeFrame: 1 year
measure: Aspartate aminotransferase (AST)
timeFrame: 1 year
measure: alanine aminotransferase (ALT)
timeFrame: 1 year
measure: alanine aminotransferase (ALT)
timeFrame: 1 year
Locations:
city: Shenyang
country: China
facility: Shenyang Northen Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Geng Wang, Dr
role: STUDY_DIRECTOR
References: