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PRAsugrel or clopIdogrel in Acute Coronary SyndromE Patients With CYP2C19 Polymorphism Before Percutaneous Coronary Intervention

Information source: Dong-A University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndromes

Intervention: Prasugrel (Drug); Clopidogrel (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Dong-A University

Official(s) and/or principal investigator(s):
Moo Hyun Kim, MD, Principal Investigator, Affiliation: Director, Regional Clinical Trial Center

Overall contact:
Moo Hyun Kim, MD, Phone: +82-51-240-2976, Email: kimmh@dau.ac.kr

Summary

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: HPR 1 day

Secondary outcome:

MACE

Bleeding

HPRs

HPR by VASP at 24 hours

HPR by VASP at 30 days

Detailed description: 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 20 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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Acute coronary syndrome

- Patients planned to undergo percutaneous transluminal coronary angioplasty

- Patients who agreed to the experimental plan which was permitted by IRB

Exclusion Criteria:

- Low body weight (< 50kg)

- History of stroke or transient ischemic attack

- History of upper gastrointestinal bleeding in recent 6 months

- Renal dysfunction defined by serum creatinine > 2. 5 mg/dl

- Severe hepatic dysfunction defined by Child-Pugh criteria B or C

- Bleeding tendency

- Anticoagulation treatment including warfarin

- Thrombocytopenia defined by platelet < 100,000/ml

- Anemia defined by hemoglobin < 10 g/dl

- Contraindication for antiplatelet treatment or anticoagulation treatment

- History of administer glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to

Locations and Contacts

Moo Hyun Kim, MD, Phone: +82-51-240-2976, Email: kimmh@dau.ac.kr

DongA University Hospital, Busan, Korea, Republic of; Recruiting
Moo Hyun Kim, MD, Phone: +82-51-240-2976, Email: kimmh@dau.ac.kr
Moo Hyun Kim, MD, Principal Investigator
Additional Information

Starting date: October 2013
Last updated: February 9, 2015

Page last updated: August 23, 2015

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