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
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
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.
ClopidogrelReloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days
Start Date: September 2012
Completed Date: December 2014
Phase: Phase 3
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