Clinical trial NCT01930591: Ticagrelor for PCI Post Thrombolysis
Official title: The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: fibrinolytic therapy
stenting
platelet activity
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Prairie Vascular Research Inc.
First posted: 2013-08-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The newer antiplatelet agents such as Ticagrelor have demonstrated superiority to Clopidogrel in patients presenting with acute coronary syndrome (ACS). At present Ticagrelor remains a first line therapy as an adjunct to aspirin for patients undergoing primary PCI for STEMI for reducing major adverse events. However, the safety and efficacy of Ticagrelor has not been investigated in patients with STEMI post fibrinolysis. Ticagrelor results in significantly higher platelet inhibition than aspirin or clopidogrel and may expose patients to an increased risk of bleeding if administered post thrombolysis. However, fibrinolytic therapy itself results in a prothrombotic milieu with greater activation of platelets, a condition that can be balanced with addition of stronger antiplatelet agents. Similar concerns were initially reflected for clopidogrel as an adjunct to fibrinolytic therapy but were later proven to be unsubstantiated. In fact, adjunct administration of clopidogrel to fibrinolytic therapy reduces major adverse events as shown by multiple studies and has become the standard of care recommended by guidelines. The present study is proposed to study the safety and efficacy of Ticagrelor in patients undergoing PCI post fibrinolytic therapy for STEMI.

Eligibility 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.

Primary outcomes:
measure: Therapeutic platelet inhibition
timeFrame: 4 hours
Secondary outcomes:
measure: Therapeutic platelet inhibition
timeFrame: 24 hours
Other outcomes:
measure: MACE
timeFrame: 24 hours or discharge
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Regina
country: Canada
facility: Prairie Vascular Research Inc. (PVRI), Regina General Hospital
state: Saskatchewan
Study officials:
affiliation: Prairie Vascular Research Network, Regina, Saskatchewan
name: Payam Dehghani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, Toronto, Ontario
name: Asim Cheema, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehghani P, Lavoie A, Lavi S, Crawford JJ, Harenberg S, Zimmermann RH, Booker J, Kelly S, Cantor WJ, Mehta SR, Bagai A, Goodman SG, Cheema AN. Effects of ticagrelor versus clopidogrel on platelet function in fibrinolytic-treated STEMI patients undergoing early PCI. Am Heart J. 2017 Oct;192:105-112. doi: 10.1016/j.ahj.2017.07.013. Epub 2017 Jul 20.