Clinical trial NCT01372839: Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
Official title: The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Unstable Angina
Keywords: Myocardial Infarction
Unstable Angina
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
timeFrame: 30-day
Secondary outcomes:
measure: Post-procedural change of inflammatory biomarkers (hs-CRP)
timeFrame: 24h
measure: Morbidity of CIN
timeFrame: 48h
measure: Elevation of ALT, AST and CK
timeFrame: 6 months
measure: Number of Participants with Adverse Events
timeFrame: 6 months
measure: Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events
timeFrame: 6 months
measure: serum adiponectin concentration
timeFrame: 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Division of Cardiology, Peking University First Hospital
name: Yong Huo, MD
role: STUDY_DIRECTOR
References: