A Phase 3 interventional study of Prasugrel and Clopidogrel in Acute Coronary Syndromes, sponsored by Dong-A University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Dong-A University · Phase 3, Interventional, and Prevention
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.
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.
1,462 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 70 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
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Exclusion Criteria:
Loading and maintenance dose of prasugrel
Drug: Prasugrel
Loading and maintenance dose of clopidogrel
Drug: Clopidogrel
Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg
Also known as: Effient
Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
Also known as: Plavix, Plavitor
HPR 1 day
High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI
Time frame: 24 hours after PCI
MACE
Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)
Time frame: 30 days
Bleeding
Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria
Time frame: 30 days
HPRs
High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI
Time frame: 4 hours after PCI, 30 days after PCI
HPR by VASP at 24 hours
HPR defined by VASP at 24 hours after PCI
Time frame: 24 hours from PCI
HPR by VASP at 30 days
HPR by VASP at 30 days from PCI
Time frame: 30 days from PCI
Plan to share: Undecided
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Dong-A University