NCT01930591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2014

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.4 years

First QC Date

August 22, 2013

Last Update Submit

November 21, 2016

Conditions

Acute Myocardial Infarction

Keywords

fibrinolytic therapystentingplatelet activity

Outcome Measures

Primary Outcomes (1)

  • Therapeutic platelet inhibition

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

    4 hours

Secondary Outcomes (1)

  • Therapeutic platelet inhibition

    24 hours

Other Outcomes (1)

  • MACE

    24 hours or discharge

Study Arms (2)

Clopidogrel arm

ACTIVE COMPARATOR

Clopidogrel 300 mg before PCI followed by 75 mg po OD

Drug: Clopidogrel

Ticagrelor arm

EXPERIMENTAL

Ticagrelor 180 mg before PCI followed by 90 mg po BID

Drug: Ticagrelor

Interventions

TicagrelorDRUG

180 mg bolus followed by 90 mg BID

Also known as: Brilinta
Ticagrelor arm
ClopidogrelDRUG

300 mg bolus followed by 75 mg OD

Also known as: Plavix
Clopidogrel arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2R2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

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

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28938956DERIVED

MeSH Terms

Interventions

TicagrelorClopidogrel

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Payam Dehghani, MD

    Prairie Vascular Research Network, Regina, Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Asim Cheema, MD

    St. Michael's Hospital, Toronto, Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 29, 2013

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(5)