Overview

Ticagrelor for PCI Post Thrombolysis

Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
Summary
Ticagrelor is a first line therapy along with aspirin for patients undergoing primary PCI for STEMI. However, many patients are still treated with fibrinolytic therapy and the safety and efficacy of Ticagrelor has not been investigated in this patients population. The present study is proposed to study the safety and efficacy of Ticagrelor in patients undergoing PCI post fibrinolytic therapy for STEMI.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Michael's Hospital, Toronto
Unity Health Toronto
Collaborator:
Prairie Vascular Research Inc.
Treatments:
Clopidogrel
Ticagrelor
Criteria
Inclusion Criteria:

1. Age 18 years and over.

2. Planned PCI between 4-24 hours after administration of fibrinolytic therapy for STEMI.

3. Treatment with aspirin and clopidogrel as an adjunct to fibrinolytic therapy.

4. Informed written consent.

Exclusion Criteria:

1. Atrial fibrillation or need for systemic anticoagulation therapy.

2. Prior PCI or coronary artery bypass grafting during past 3 months.

3. Active bleeding or high risk of bleeding based upon clinical assessment.

4. Known severe liver or renal disease or patient requiring dialysis.

5. Concomitant oral or IV therapy with strong cytochrome (CYP3A) inhibitors which cannot
be stopped.

6. Contraindication to ticagrelor or clopidogrel.

7. Planned surgery during the study period.

8. Any of the following in the absence of a functioning implanted pacemaker: sick sinus
syndrome, 2nd or 3rd degree AVB, documented syncope of suspected bradycardic origin.

9. Known clinically important thrombocytopenia or anemia.

10. Known pregnancy or lactation.

11. Condition which may either put the patient at risk or influence the result of the
study.

12. Previous randomization in this SETFAST study.

13. Participation in another clinical study with an investigational product or device
study over the past 30 days.