PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants (PRAISE-GENE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01641510
Recruitment Status : Recruiting
First Posted : July 16, 2012
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: Prasugrel Drug: Clopidogrel Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : October 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Prasugrel
Loading and maintenance dose of prasugrel
Drug: 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
Drug: Clopidogrel
Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
Other Names:
  • Plavix
  • Plavitor

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01641510

Contact: Moo Hyun Kim, MD +82-51-240-2976
Contact: Dong Hyun Lee, MD +82-51-240-5040

Korea, Republic of
DongA University Hospital Recruiting
Busan, Korea, Republic of
Contact: Moo Hyun Kim, MD    +82-51-240-2976   
Principal Investigator: Moo Hyun Kim, MD         
Sponsors and Collaborators
Dong-A University
Principal Investigator: Moo Hyun Kim, MD Director, Regional Clinical Trial Center

Responsible Party: Moo Hyun Kim, MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital, Dong-A University Identifier: NCT01641510     History of Changes
Other Study ID Numbers: PRAISE-GENE
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Moo Hyun Kim, Dong-A University:
reduced-function CYP2C19 allele
high platelet reactivity

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors