PRAsugrel or clopIdogrel in Acute Coronary SyndromE Patients With CYP2C19 Polymorphism Before Percutaneous Coronary Intervention (PRAISE-GENE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Dong-A University
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University
ClinicalTrials.gov Identifier:
NCT01641510
First received: July 2, 2012
Last updated: January 28, 2014
Last verified: January 2014

July 2, 2012
January 28, 2014
October 2013
December 2014   (final data collection date for primary outcome measure)
HPR 1 day [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]
High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI
HPR 1 day [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]
High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 24 hours after PCI
Complete list of historical versions of study NCT01641510 on ClinicalTrials.gov Archive Site
  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)
  • Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria
  • HPRs [ Time Frame: 4 hours after PCI, 30 days after PCI ] [ Designated as safety issue: No ]
    High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI
  • HPR by VASP at 24 hours [ Time Frame: 24 hours from PCI ] [ Designated as safety issue: No ]
    HPR defined by VASP at 24 hours after PCI
  • HPR by VASP at 30 days [ Time Frame: 30 days from PCI ] [ Designated as safety issue: No ]
    HPR by VASP at 30 days from PCI
  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)
  • Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria
  • HPRs [ Time Frame: 4 hours after PCI, 30 days after PCI ] [ Designated as safety issue: No ]
    High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI
Not Provided
Not Provided
 
PRAsugrel or clopIdogrel in Acute Coronary SyndromE Patients With CYP2C19 Polymorphism Before Percutaneous Coronary Intervention
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.

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 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Acute Coronary Syndromes
  • Drug: Prasugrel
    Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg
    Other Name: Effient
  • Drug: Clopidogrel
    Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
    Other Names:
    • Plavix
    • Plavitor
  • Experimental: Prasugrel
    Loading and maintenance dose of prasugrel
    Intervention: Drug: Prasugrel
  • Active Comparator: Clopidogrel
    Loading and maintenance dose of clopidogrel
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Moo Hyun Kim, MD +82-51-240-2976 kimmh@dau.ac.kr
Contact: Dong Hyun Lee, MD +82-51-240-5040 rvot@daum.net
Korea, Republic of
 
NCT01641510
PRAISE-GENE
Yes
Moo Hyun Kim, Dong-A University
Dong-A University
Not Provided
Principal Investigator: Moo Hyun Kim, MD Director, Regional Clinical Trial Center
Dong-A University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP