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Completed

NCT Number: NCT01641510

PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DongA University Hospital

Busan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prasugrel

Drug

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

Other names: Effient

clopidogrel

Drug

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

Other names: Plavix, Plavitor

Primary outcomes

  1. HPR 1 day

    Time frame: 24 hours after PCI

    High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI

Secondary outcomes

  1. MACE

    Time frame: 30 days

    Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)

  2. Bleeding

    Time frame: 30 days

    Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria

  3. HPRs

    Time frame: 4 hours after PCI, 30 days after PCI

    High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI

  4. HPR by VASP at 24 hours

    Time frame: 24 hours from PCI

    HPR defined by VASP at 24 hours after PCI

  5. HPR by VASP at 30 days

    Time frame: 30 days from PCI

    HPR by VASP at 30 days from PCI

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study 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.

Acronym: PRAISE-GENE

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Jul 16, 2012
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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