Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI) (spirit)
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|ClinicalTrials.gov Identifier: NCT01371058|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : December 16, 2015
Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
The aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: high maintenance clopidogrel Drug: routine dual antiplatelet Drug: policosanol plus dual antiplatelet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)|
|Study Start Date :||March 2011|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2013|
Active Comparator: routine dual antiplatelet
asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.
Drug: routine dual antiplatelet
clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
Experimental: high maintenance clopidogrel
aspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year.
Drug: high maintenance clopidogrel
clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
Experimental: policosanol plus dual antiplatelet
asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.
Drug: policosanol plus dual antiplatelet
aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months
- reversion rate of HPR [ Time Frame: 30 days ]reversion was defined as platelet aggregation <65%
- major adverse cardiovascular events [ Time Frame: 1 year ]including cardiac death, non-fatal myocardial infarction and target vessel revascularization
- Stent thrombosis and TIMI bleeding events [ Time Frame: 1 year ]
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): NCT01371058
|The First Hospital of China Medical University|
|Shenyang, Liaoning, China, 110001|
|Principal Investigator:||Yaling Han, MD||Shenyang Northern Hospital|