Effects of Intensive Statin Treatment on Left Ventricular Function

Phase 4

• Conditions: Acute Anterior Myocardial Infarction
• Interventions: Drug: standard group; Drug: intensive group

• Registration Number: NCT01936103
• Lead Sponsor: Shenyang Northern Hospital

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-04-23
• Status Verified: 2013-08
• Study First Submitted QC: 2013-09-02
• Last Update Submitted: 2013-09-02
• Study First Posted: 2013-09-05
• Last Update Posted: 2013-09-05
• Primary Completion: 2014-05
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard group	standard group	patients in this group received standard statin treatment： Atorvastatin statins 20mg / night .
intensive group	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 .

Primary Outcome Measures

Name	Time	Method
left ventricular function	30 days	ultrasonic observation of E/A

Secondary Outcome Measures

Name	Time	Method
the left ventricular function	1 year
plasma brain natriuretic peptide	1 year

Trial Locations

Locations (1)

Shenyang Northen Hospital; 🇨🇳 Shenyang, Liaoning, China