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Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention (PRAISE-HPR)

This study is currently recruiting participants.
Verified September 2012 by Dong-A University
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University
ClinicalTrials.gov Identifier:
NCT01609647
First received: May 29, 2012
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing percutaneous coronary intervention (PCI) is related to high risk of short and long term recurrent ischemic events including stent thrombosis.

The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in lower risk of short term recurrent ischemic events.


Condition Intervention Phase
Acute Coronary Syndrome
 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: Comparison of Prasugrel and Clopidogrel Reloading on High Platelet Reactivity in Clopidogrel-loaded Patients Undergoing Percutaneous Coronary Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dong-A University:

Primary Outcome Measures:
  • HPR at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Persistently high platelet reactivity after PCI. PRU is measured by methods of VerifyNow device and HPRU is defined as PRU of 240 or more.


Secondary Outcome Measures:
  • MACE [ Time Frame: 30 days (1 month) ] [ 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 (1 month) ] [ 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 ]
    Persistently high platelet reactivity 4 hours and 30 days after PCI. PRU is measured by methods of VerifyNow device and HPRU is defined as PRU of 240 or more.


Estimated Enrollment: 76
Study Start Date: September 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel
Reloading with prasugrel 20mg & followed by administration of 5mg/day for 30 days
 Drug: Prasugrel
Reloading with prasugrel 20mg and followed by daily administration of prasugrel 5mg for 30 days
Other Name: Effient
Active Comparator: Clopidogrel
Reloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days
 Drug: Clopidogrel
Reloading with clopidogrel 300mg and followed by daily administration of clopidogrel 75mg for 30 days
Other Name: Plavix

Detailed Description:

Dual antiplatelet therapy with acetylsalicyclic acid (ASA) and additional clopidogrel is now standard regimen for the prevention of recurrent ischemic events in patients who undergo PCI.

But decreased effect of clopidogrel in a group of patients was reported and they are known to be associated with high risk of recurrent ischemic event. Decreased effect of clopidogrel is mainly resulted from decreased function to metabolite prodrug, clopidogrel to active form of drug.

Prasugrel, newer thienopyridine has been recently developed and showed advantages to clopidogrel. Prasugrel is known to have shorter onset time to achieve steady state level than clopidogrel and constant pharmacologic effect regardless of patient diversity.

High PRU after loading dose clopidogrel in patients undergoing PCI is known to be related to increased risk of short and long term recurrent ischemic events including stent thrombosis. Prasugrel has been reported to be effective in reducing platelet reactivity in patients showing resistance to clopidogrel and high PRU.

The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in reduced risk of short term recurrent ischemic events.

The investigators plan to include 70 acute coronary syndrome patients who are planned to undergo PCI and show high platelet reactivity. Most patients with ACS administer loading dose of ASA and clopidogrel as soon as they are assumed to be ACS.

The investigators plan to perform platelet reactivity test by VeryfyNow (VN) before PCI and enroll patients with high PRU defined by 240 or more. They are to randomly administered additional 300mg of clopidogrel or 20mg of prasugrel.

  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)
  • Urgent PCI for ACS
  • Use of glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to
  • History of transient ischemic attack
  • History of upper gastrointestinal bleeding in recent 6 months
  • Renal dysfunction defined as serum creatinine > 2.5 mg/dl
  • Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit
  • Bleeding tendency
  • Anticoagulation treatment including warfarin
  • Thrombocytopenia defined by platelet < 100,000/ml
  • Anemia defined by hemoglobin < 10 g/dl
  • Contraindication for study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609647

Contacts
Contact: Moo Hyun Kim, MD +82-51-240-2976 kimmh@dau.ac.kr
Contact: Dong Hyun Lee, MD +82-51-240-5040 insulin@empal.com

Locations
Korea, Republic of
DongA University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Moo Hyun Kim, MD     +82-51-240-2976     kimmh@dau.ac.kr    
Sponsors and Collaborators
Dong-A University
Investigators
Principal Investigator: Moo Hyun Kim, MD Director, Regional Clinical Trial Center
  More Information

No publications provided by Dong-A University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: NCT01609647     History of Changes
Other Study ID Numbers: PRAISE-HPR
Study First Received: May 29, 2012
Last Updated: September 25, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Dong-A University:
High plate reactivity unit after loading dose of clopidogrel

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 May 22, 2013