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Acute Coronary Syndrome | Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention

Acute Coronary Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Coronary Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PrasugrelReloading with prasugrel 20mg and followed by daily administration of prasugrel 5mg for 30 days

Drug:ClopidogrelReloading with clopidogrel 300mg and followed by daily administration of clopidogrel 75mg for 30 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Prasugrel

ClopidogrelReloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days

Study Status

Completed

Start Date: September 2012

Completed Date: December 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: HPR at 24 hours

Secondary Outcome: MACE

Study sponsors, principal investigator, and references

Principal Investigator: Moo Hyun Kim, MD

Lead Sponsor: Dong-A University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01609647

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