Ticagrelor for PCI Post Thrombolysis

Phase 3

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor

• Registration Number: NCT01930591
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-29
• Study Start: 2014-05
• Primary Completion: 2016-10
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel arm	Clopidogrel	Clopidogrel 300 mg before PCI followed by 75 mg po OD
Ticagrelor arm	Ticagrelor	Ticagrelor 180 mg before PCI followed by 90 mg po BID

Primary Outcome Measures

Name	Time	Method
Therapeutic platelet inhibition	4 hours	Therapeutic platelet inhibition as determined by VerifyNow assay (PRU value \<208) at 4±1 hours post PCI

Secondary Outcome Measures

Name	Time	Method
Therapeutic platelet inhibition	24 hours	Therapeutic platelet inhibition (PRU value \<208) at 24±4 hours post PCI.

Trial Locations

Locations (5)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Prairie Vascular Research Inc. (PVRI), Regina General Hospital; 🇨🇦 Regina, Saskatchewan, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada