Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01372839

Collaborator

(none)

300

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Unstable Angina	Drug: Atorvastatin Drug: Statin	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care	Drug: Atorvastatin Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Other: Usual care statin dose should not be higher than that described in exclusion criteria.	Drug: Statin Usual care, but statin dose should not be higher than that described in exclusion criteria

Arm

Intervention/Treatment

Active Comparator: Atorvastatin

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

Drug: Atorvastatin

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

Other: Usual care

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

Drug: Statin

Usual care, but statin dose should not be higher than that described in exclusion criteria

Outcome Measures

Primary Outcome Measures

30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI [30-day]

Secondary Outcome Measures

Post-procedural change of inflammatory biomarkers (hs-CRP) [24h]
Morbidity of CIN [48h]
Elevation of ALT, AST and CK [6 months]
Proportion of patients who experience at least once AST>3UNL，ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment.
Number of Participants with Adverse Events [6 months]
Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events [6 months]
Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
serum adiponectin concentration [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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