Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Center of South Arkansas
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

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) -