Effects of Intensive Statin Treatment on Left Ventricular Function

Acute Anterior Myocardial Infarction Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01936103
• Other study ID #: NH-20120404
• Status: Recruiting
• Phase: Phase 4
• First received: April 23, 2013
• Last updated: September 2, 2013
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2013
• Source: Shenyang Northern Hospital
• Contact: Geng Wang, Dr
• Phone: +86-24-28897280
• Email: Wanggeng69[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Anterior Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• standard group
standard statin treatment:Atorvastatin statins 20mg / night .
• intensive group
intensive statin treatment: Admission atorvastatin statins the 80mg, after surgery,atorvastatin 40mg / night,and until 30 days after the operation

Locations

Country	Name	City	State
China	Shenyang Northen Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	enzymes	the level of CK peak	1 year	No
Other	Major adverse cardiac and cerebral events at 1 year	1 year after death, cardiac death , myocardial infarction , heart failure , cardiac causes hospitalization , revascularization combined endpoint of cerebrovascular events .	1 year	No
Other	Aspartate aminotransferase (AST)	Aspartate aminotransferase (AST) returned to normal in the perioperative period	1 year	Yes
Other	enzymes	CK-MB peak	1 year	Yes
Other	enzymes	troponin (TnT)	1 year	Yes
Other	enzymes	CK-MB peak time	1 year	Yes
Other	Aspartate aminotransferase (AST)	any elevation> 3 times the proportion	1 year	Yes
Other	alanine aminotransferase (ALT)	alanine aminotransferase (ALT)returned to normal in the perioperative period	1 year	Yes
Other	alanine aminotransferase (ALT)	any elevation> 3 times the proportion	1 year	Yes
Primary	left ventricular function	ultrasonic observation of left ventricular end-diastolic diameter	30 days	No
Primary	left ventricular function	ultrasonic observation of left ventricular end-systolic volume	30 days	No
Primary	left ventricular function	ultrasonic observation of left ventricular fractional shortening RWSI	30 days	No
Primary	left ventricular function	ultrasonic observation of the left ventricular ejection fraction	30 days	No
Primary	left ventricular function	ultrasonic observation of E/A	30 days	No
Secondary	the left ventricular function		6 months	No
Secondary	the left ventricular function		1 year	No
Secondary	plasma brain natriuretic peptide		30days	No
Secondary	plasma brain natriuretic peptide		6 months	No
Secondary	plasma brain natriuretic peptide		1 year	No