Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
NCT ID: NCT01372839
Last Updated: 2011-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atorvastatin
80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
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 dose should not be higher than that described in exclusion criteria.
Statin
Usual care, but statin dose should not be higher than that described in exclusion criteria
Interventions
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Atorvastatin
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Statin
Usual care, but statin dose should not be higher than that described in exclusion criteria
Eligibility Criteria
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Inclusion Criteria
* Patients with clinical diagnosis of ACS
* Evidence of a personally signed and dated informed consent document
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Department of Cardiology of Xijing Hospital; Fourth Military Medical University
Principal Investigators
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Yong Huo, MD
Role: STUDY_DIRECTOR
Division of Cardiology, Peking University First Hospital
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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xj050511
Identifier Type: -
Identifier Source: org_study_id
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