Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI
NCT ID: NCT01293097
Last Updated: 2013-04-30
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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COMPLETED
PHASE4
2884 participants
INTERVENTIONAL
2010-06-30
2011-10-31
Brief Summary
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Detailed Description
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2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30 days after PCI while the control group receive usual care. The last visit will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after procedure will be recorded. 1100 effective patients will be finally enrolled.
The study will be conducted at about 54 centers in China. Data will be collected on 2,100 NSTE or SAP patients undergoing PCI.
Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at least once AST \> 3ULN，ALT \> 3ULN or CK \> 5ULN after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK\>ULN after initiation of study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensive statin therapy
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
Usual care, but 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography
* Evidence of a personally signed and dated informed consent document
Exclusion Criteria
* Experienced STEMI within previous 30 days
* Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
* Anticipated repeated PCI within 6 months
* 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)
* White blood cell \< 4×109/L or platelet \< 100×109/L
* 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
20 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Yong Huo
Director, Department of cardiology
Principal Investigators
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Yong Huo, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Division of Cardiology, Peking University First Hospital
Beijing, , China
Countries
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Other Identifiers
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ISCAP
Identifier Type: -
Identifier Source: org_study_id