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
  Purpose

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 Intervention Phase
Acute Coronary Syndromes
Drug: Prasugrel
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Dong-A University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641510

Contacts
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

Locations
Korea, Republic of
DongA University Hospital Recruiting
Busan, Korea, Republic of
Contact: Moo Hyun Kim, MD    +82-51-240-2976    kimmh@dau.ac.kr   
Principal Investigator: Moo Hyun Kim, MD         
Sponsors and Collaborators
Dong-A University
Investigators
Principal Investigator: Moo Hyun Kim, MD Director, Regional Clinical Trial Center
  More Information

No publications provided

Responsible Party: Moo Hyun Kim, MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital, Dong-A University
ClinicalTrials.gov Identifier: NCT01641510     History of Changes
Other Study ID Numbers: PRAISE-GENE
Study First Received: July 2, 2012
Last Updated: January 28, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Dong-A University:
reduced-function CYP2C19 allele
high platelet reactivity
clopidogrel
prasugrel

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014