PRAsugrel or clopIdogrel in Acute Coronary SyndromE Patients With CYP2C19 Polymorphism (PRAISE-GENE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 3 Study Comparing the Efficacy and Safety of Prasugrel and Clopidogrel in Acute Coronary Syndrome Patients With CYP2C19 Polymorphism Who Undergo Percutaneous Coronary Intervention.|
- HPR 1 day [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI
- MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)
- Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria
- HPRs [ Time Frame: 4 hours after PCI, 30 days after PCI ] [ Designated as safety issue: No ]High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI
- HPR by VASP at 24 hours [ Time Frame: 24 hours from PCI ] [ Designated as safety issue: No ]HPR defined by VASP at 24 hours after PCI
- HPR by VASP at 30 days [ Time Frame: 30 days from PCI ] [ Designated as safety issue: No ]HPR by VASP at 30 days from PCI
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Loading and maintenance dose of prasugrel
Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg
Other Name: Effient
Active Comparator: Clopidogrel
Loading and maintenance dose of clopidogrel
Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
Antiplatelet treatment is recommended worldwide for the secondary prevention and clopidogrel is an essential drug. But clopidogrel has limited value because of its pharmacodynamic interpatient variability and delayed onset time.
It is well known that patients who carry a common reduced-function CYP2C19 allele have a lower level of active metabolite of clopidogrel, diminished platelet inhibition, and furthermore, higher rate of major adverse cardiovascular events than noncarriers.
To achieve maximum plateau more rapidly and reduce the rate of high on-treatment platelet reactivity, higher loading dose of clopidogrel, up to 600 mg, is recommended. Although, however, the higher loading dose of clopidogrel, many patients still remain as non-responder.
Incidence of patients with clopidogrel resistance, especially CYP2C19*2 and *3, which encounter loss function, is higher in Eastern Asian peoples than Western peoples. Some studies report incidence rate of clopidogrel resistance in Eastern Asian peoples up to 99%.
However, the metabolism is not influenced by the presence of CYP2C19 genetic variation and prasugrel shows potent platelet inhibition. Although prasugrel exhibit potent platelet inhibition, recent reports describe the possible over inhibition of platelet especially in the East Asian people.
The investigators are going to compare the efficacy and safety of loading dose of prasugrel 30 mg which is lower than conventional loading dose followed by 5 mg/day which is also lower than conventional maintenance dose for 30 days and loading dose of clopidogrel 600 mg followed by 75 mg/day for 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641510
|Contact: Moo Hyun Kim, MDemail@example.com|
|Contact: Dong Hyun Lee, MDfirstname.lastname@example.org|
|Korea, Republic of|
|DongA University Hospital||Recruiting|
|Busan, Korea, Republic of|
|Contact: Moo Hyun Kim, MD +82-51-240-2976 email@example.com|
|Principal Investigator: Moo Hyun Kim, MD|
|Principal Investigator:||Moo Hyun Kim, MD||Director, Regional Clinical Trial Center|