Acute ST Segment Elevation Myocardial Infarction | Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis
Acute ST Segment Elevation Myocardial Infarction research study
What is the primary objective of this study?
This study involves doing platelet function testing in patients who have undergone fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of care to restore blood flow in blocked arteries as soon as possible after the \"Heart attack\" in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the damage of the myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing fibrinolysis has been well studied in many trials. In this study investigators will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs (Pharmacokinetics).
Who is eligible to participate?
Inclusion Criteria: 1. Men and women 18 to 75 years of age 2. Ischemic discomfort lasting more than 20 mins at rest within 12 hours before randomization 3. ST-segment elevation of at least 0.1 mV in at least two contiguous limb leads, ST-segment elevation of at least 0.2 mV in at least two contiguous precordial leads, or left bundle-branch block that was not known to be old 4. Received fibrinolytic agent, an anticoagulant (if a fibrin-specific lytic agent was prescribed) and aspirin within 24-48 hours Exclusion Criteria: 1. Hypersensitivity to ticagrelor or clopidogrel 2. Active Pathological Bleeding or history of intracranial bleeding 3. Concomitant use of oral anticoagulant 4. Concomitant use of 40 mg of Simvastatin or lovastatin 5. Concomitant strong CYP3A inhibitors such as ketoconazole, clarithromycin, nefazadone, ritonavir, atazanavir 6. Concomitant use of CYP2C19 inhibitors such as omeprazole or esomeprazole 7. Patients planned to urgent CABG 8. Thrombocytopenia 9. Dialysis 10. Use of oral antiplatelet agent (ticagrelor, prasugrel, Clopidogrel) within 7 days prior to enrollment 11. Use of GP IIb/IIIa inhibitors 12. Rescue PCI (PCI < 24 hours from symptom onset) -
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute ST Segment Elevation Myocardial Infarction
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:TicagrelorFor ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid.
Drug:ClopidogrelFor clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD
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.
TicagrelorTicagrelor Arm will be dosed with a loading dose of 180 mg followed by maintenance dose of 90 mg BID until discharge or up to 8 days.
ClopidogrelClopidogrel arm will be dose with a loading dose of 300 mg followed by maintenance dose of 75 mg everyday until discharge or up to 8 days.
Start Date: January 2, 2014
Completed Date: March 2018
Phase: Phase 4
Primary Outcome: Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow
Secondary Outcome: Pharmacokinetic (AUC, Cmax, Tmax)
Study sponsors, principal investigator, and references
Principal Investigator: Rakesh K Sharma, MD, FACC, FSCAI, FSCCT
Lead Sponsor: Medical Center of South Arkansas