Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome (PCI)
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|ClinicalTrials.gov Identifier: NCT01372839|
Recruitment Status : Unknown
Verified July 2010 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : June 14, 2011
Last Update Posted : June 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Unstable Angina||Drug: Atorvastatin Drug: Statin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2012|
Active Comparator: Atorvastatin
80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
statin dose should not be higher than that described in exclusion criteria.
Usual care, but statin dose should not be higher than that described in exclusion criteria
- 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI [ Time Frame: 30-day ]
- Post-procedural change of inflammatory biomarkers (hs-CRP) [ Time Frame: 24h ]
- Morbidity of CIN [ Time Frame: 48h ]
- Elevation of ALT, AST and CK [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372839
|Contact: Ling Tao, M.D Ph.Dfirstname.lastname@example.org|
|Xi'an, Shaanxi, China, 710032|
|Contact: Ling Tao, M.D Ph.D +86-15002955798 email@example.com|
|Principal Investigator: Ling Tao, M.D Ph.D|
|Study Director:||Yong Huo, MD||Division of Cardiology, Peking University First Hospital|