PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants

NCT ID: NCT01641510

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-02-28

Brief 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.

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 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.

Conditions

Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Prasugrel

Loading and maintenance dose of prasugrel

Group Type: EXPERIMENTAL

Prasugrel

Intervention Type: DRUG

Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg

Clopidogrel

Loading and maintenance dose of clopidogrel

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg

Interventions

Prasugrel

Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg

Intervention Type: DRUG

Clopidogrel

Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg

Intervention Type: DRUG

Other Intervention Names

Effient; Plavix; Plavitor

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-A University

OTHER

Sponsor Role: lead

Responsible Party

Moo Hyun Kim

MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moo Hyun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Regional Clinical Trial Center

Locations

DongA University Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

PRAISE-GENE

Identifier Type: -

Identifier Source: org_study_id