Ticagrelor for PCI Post Thrombolysis

NCT ID: NCT01930591

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Acute Myocardial Infarction

Keywords

fibrinolytic therapy; stenting; platelet activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel arm

Clopidogrel 300 mg before PCI followed by 75 mg po OD

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

300 mg bolus followed by 75 mg OD

Ticagrelor arm

Ticagrelor 180 mg before PCI followed by 90 mg po BID

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

180 mg bolus followed by 90 mg BID

Interventions

Ticagrelor

180 mg bolus followed by 90 mg BID

Intervention Type: DRUG

Clopidogrel

300 mg bolus followed by 75 mg OD

Intervention Type: DRUG

Other Intervention Names

Brilinta; Plavix

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prairie Vascular Research Inc.

INDUSTRY

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Payam Dehghani, MD

Role: PRINCIPAL_INVESTIGATOR

Prairie Vascular Research Network, Regina, Saskatchewan

Asim Cheema, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, Toronto, Ontario

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

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

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28938956 (View on PubMed)

Other Identifiers

104

Identifier Type: -

Identifier Source: org_study_id