Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Phase 4

• Conditions: Myocardial Infarction; Unstable Angina
• Interventions: Drug: Atorvastatin; Drug: Statin

• Registration Number: NCT01372839
• Lead Sponsor: Xijing Hospital

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.

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 Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-11
• Last Update Submitted: 2011-06-11
• Study First Posted: 2011-06-14
• Last Update Posted: 2011-06-14
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin	80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Usual care	Statin	statin dose should not be higher than that described in exclusion criteria.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China