Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Unstable Angina; Myocardial Infarction

Treatments: Drug: Atorvastatin; Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT01372839

xj050511

Details and patient eligibility

About

Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

Full description

This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-85 years old
• Patients with clinical diagnosis of ACS
• Evidence of a personally signed and dated informed consent document

Exclusion criteria

• Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
• LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
• Endstage congestive heart failure, or LVEF < 30%
• Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
• Myopathy or increased creatine kinase (CK>2 UNL)
• Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
• Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
• Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
• Pregnancy, lactation, or child bearing potential women without any effective contraception
• Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
• Participating in other interventional clinical trails using drugs or devices
• Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Atorvastatin

Active Comparator group

Description:

80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Treatment:

Drug: Atorvastatin

Usual care

Other group

Description:

statin dose should not be higher than that described in exclusion criteria.

Treatment:

Drug: Statin