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Ticagrelor for PCI Post Thrombolysis (SETFAST)

Primary Purpose

Acute Myocardial Infarction

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Ticagrelor

Clopidogrel

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring fibrinolytic therapy, stenting, platelet activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 years and over.
Planned PCI between 4-24 hours after administration of fibrinolytic therapy for STEMI.
Treatment with aspirin and clopidogrel as an adjunct to fibrinolytic therapy.
Informed written consent.

Exclusion Criteria:

Atrial fibrillation or need for systemic anticoagulation therapy.
Prior PCI or coronary artery bypass grafting during past 3 months.
Active bleeding or high risk of bleeding based upon clinical assessment.
Known severe liver or renal disease or patient requiring dialysis.
Concomitant oral or IV therapy with strong cytochrome (CYP3A) inhibitors which cannot be stopped.
Contraindication to ticagrelor or clopidogrel.
Planned surgery during the study period.
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.
Known clinically important thrombocytopenia or anemia.
Known pregnancy or lactation.
Condition which may either put the patient at risk or influence the result of the study.
Previous randomization in this SETFAST study.
Participation in another clinical study with an investigational product or device study over the past 30 days.

Sites / Locations

Hamilton General Hospital
London Health Sciences Centre
Southlake Regional Health Centre
St. Michael's Hospital
Prairie Vascular Research Inc. (PVRI), Regina General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clopidogrel arm

Ticagrelor arm

Arm Description

Clopidogrel 300 mg before PCI followed by 75 mg po OD

Ticagrelor 180 mg before PCI followed by 90 mg po BID

Outcomes

Primary Outcome Measures

Therapeutic platelet inhibition

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

Secondary Outcome Measures

Therapeutic platelet inhibition

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

Full Information

NCT ID

NCT01930591

First Posted

August 22, 2013

Last Updated

November 21, 2016

Sponsor

Unity Health Toronto

Collaborators

Prairie Vascular Research Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01930591

Brief Title

Ticagrelor for PCI Post Thrombolysis

Acronym

SETFAST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Prairie Vascular Research Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

fibrinolytic therapy, stenting, platelet activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel arm

Arm Type

Active Comparator

Arm Description

Clopidogrel 300 mg before PCI followed by 75 mg po OD

Arm Title

Ticagrelor arm

Arm Type

Experimental

Arm Description

Ticagrelor 180 mg before PCI followed by 90 mg po BID

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Other Intervention Name(s)

Brilinta

Intervention Description

180 mg bolus followed by 90 mg BID

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

300 mg bolus followed by 75 mg OD

Primary Outcome Measure Information:

Title

Therapeutic platelet inhibition

Description

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

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

Therapeutic platelet inhibition

Description

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

Time Frame

24 hours

Other Pre-specified Outcome Measures:

Title

MACE

Description

MACE is a composite of death, re-infarction, stroke and bleeding

Time Frame

24 hours or discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 years and over. Planned PCI between 4-24 hours after administration of fibrinolytic therapy for STEMI. Treatment with aspirin and clopidogrel as an adjunct to fibrinolytic therapy. Informed written consent. Exclusion Criteria: Atrial fibrillation or need for systemic anticoagulation therapy. Prior PCI or coronary artery bypass grafting during past 3 months. Active bleeding or high risk of bleeding based upon clinical assessment. Known severe liver or renal disease or patient requiring dialysis. Concomitant oral or IV therapy with strong cytochrome (CYP3A) inhibitors which cannot be stopped. Contraindication to ticagrelor or clopidogrel. Planned surgery during the study period. 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. Known clinically important thrombocytopenia or anemia. Known pregnancy or lactation. Condition which may either put the patient at risk or influence the result of the study. Previous randomization in this SETFAST study. Participation in another clinical study with an investigational product or device study over the past 30 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Payam Dehghani, MD

Organizational Affiliation

Prairie Vascular Research Network, Regina, Saskatchewan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Asim Cheema, MD

Organizational Affiliation

St. Michael's Hospital, Toronto, Ontario

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Southlake Regional Health Centre

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2R2

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Prairie Vascular Research Inc. (PVRI), Regina General Hospital

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4P 0W5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28938956

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.

Results Reference

derived

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