Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention
NCT ID: NCT01609647
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2012-09-30
2014-12-31
Brief Summary
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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.
Detailed Description
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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 235 or more. They are to randomly administered additional 300mg of clopidogrel or 20mg of prasugrel.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prasugrel
Reloading with prasugrel 20mg \& followed by administration of 5mg/day for 30 days
Prasugrel
Reloading with prasugrel 20mg and followed by daily administration of prasugrel 5mg for 30 days
Clopidogrel
Reloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days
Clopidogrel
Reloading with clopidogrel 300mg and followed by daily administration of clopidogrel 75mg for 30 days
Interventions
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Prasugrel
Reloading with prasugrel 20mg and followed by daily administration of prasugrel 5mg for 30 days
Clopidogrel
Reloading with clopidogrel 300mg and followed by daily administration of clopidogrel 75mg for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients planned to undergo percutaneous transluminal coronary angioplasty
* Patients who agreed to the experimental plan which was permitted by IRB
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Dong-A University
OTHER
Responsible Party
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Moo Hyun Kim
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital
Principal Investigators
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Moo Hyun Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Director, Regional Clinical Trial Center
Locations
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DongA University Hospital
Busan, , South Korea
Countries
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References
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Guo LZ, Kim MH, Shin ES, Ann SH, De Jin C, Cho YR, Park JS, Park K, Park TH, Lee MS, Serebruany VL. Thienopyridine reloading in clopidogrel-loaded patients undergoing percutaneous coronary interventions: The PRAISE study. Int J Cardiol. 2016 Nov 1;222:639-644. doi: 10.1016/j.ijcard.2016.08.027. Epub 2016 Aug 4.
Lee DH, Kim MH, Park TH, Park JS, Park K, Zhang HZ, Seo JM, Lee MS. Comparison of prasugrel and clopidogrel reloading on high platelet reactivity in clopidogrel-loaded patients undergoing percutaneous coronary intervention (PRAISE-HPR): a study protocol for a prospective randomized controlled clinical trial. Trials. 2013 Feb 28;14:62. doi: 10.1186/1745-6215-14-62.
Other Identifiers
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PRAISE-HPR
Identifier Type: -
Identifier Source: org_study_id