Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis

Withdrawn before enrolling · Phase 4

Conditions studied: Acute ST Segment Elevation Myocardial Infarction, Acute Coronary Syndrome

In brief

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).

Key facts

Study ID

NCT02048085

Run by

Medical Center of South Arkansas

People needed

0

Starts

2014-01-02

Expected to finish

2018-03-01

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women 18 to 75 years of age
• Ischemic discomfort lasting more than 20 mins at rest within 12 hours before randomization
• 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
• Received fibrinolytic agent, an anticoagulant (if a fibrin-specific lytic agent was prescribed) and aspirin within 24-48 hours

You may not qualify if…

• Hypersensitivity to ticagrelor or clopidogrel
• Active Pathological Bleeding or history of intracranial bleeding
• Concomitant use of oral anticoagulant
• Concomitant use of 40 mg of Simvastatin or lovastatin
• Concomitant strong CYP3A inhibitors such as ketoconazole, clarithromycin, nefazadone, ritonavir, atazanavir
• Concomitant use of CYP2C19 inhibitors such as omeprazole or esomeprazole
• Patients planned to urgent CABG
• Thrombocytopenia
• Dialysis
• Use of oral antiplatelet agent (ticagrelor, prasugrel, Clopidogrel) within 7 days prior to enrollment
• Use of GP IIb/IIIa inhibitors
• Rescue PCI (PCI < 24 hours from symptom onset) -

Where it is running

• Medical Center of South Arkansas — El Dorado, Arkansas, United States

Full record on ClinicalTrials.gov

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