Ticagrelor for PCI Post Thrombolysis

Acute Myocardial Infarction Clinical Trial

— SETFAST  

Official title:

The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930591
• Other study ID #: 104
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2013
• Last updated: November 21, 2016
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Ticagrelor
180 mg bolus followed by 90 mg BID
• Clopidogrel
300 mg bolus followed by 75 mg OD

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Prairie Vascular Research Inc. (PVRI), Regina General Hospital	Regina	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Prairie Vascular Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MACE	MACE is a composite of death, re-infarction, stroke and bleeding	24 hours or discharge	Yes
Primary	Therapeutic platelet inhibition	Therapeutic platelet inhibition as determined by VerifyNow assay (PRU value <208) at 4±1 hours post PCI	4 hours	No
Secondary	Therapeutic platelet inhibition	Therapeutic platelet inhibition (PRU value <208) at 24±4 hours post PCI.	24 hours	Yes