Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Ticagrelor for PCI Post Thrombolysis (SETFAST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Prairie Vascular Research Inc. Regina, Saskatchewan, Canada
Information provided by (Responsible Party):
Asim Nazir Cheema, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01930591
First received: August 22, 2013
Last updated: November 6, 2013
Last verified: November 2013

August 22, 2013
November 6, 2013
December 2013
May 2015   (final data collection date for primary outcome measure)
Therapeutic platelet inhibition [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Therapeutic platelet inhibition as determined by VerifyNow assay (PRU value <208) at 4±1 hours post PCI
Same as current
Complete list of historical versions of study NCT01930591 on ClinicalTrials.gov Archive Site
Therapeutic platelet inhibition [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Therapeutic platelet inhibition (PRU value <208) at 24±4 hours post PCI.
Same as current
MACE [ Time Frame: 24 hours or discharge ] [ Designated as safety issue: Yes ]
MACE is a composite of death, re-infarction, stroke and bleeding
Same as current
 
Ticagrelor for PCI Post Thrombolysis
The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: Ticagrelor
    180 mg bolus followed by 90 mg BID
    Other Name: Brilinta
  • Drug: Clopidogrel
    300 mg bolus followed by 75 mg OD
    Other Name: Plavix
  • Active Comparator: Clopidogrel arm
    Clopidogrel 300 mg before PCI followed by 75 mg po OD
    Intervention: Drug: Clopidogrel
  • Experimental: Ticagrelor arm
    Ticagrelor 180 mg before PCI followed by 90 mg po BID
    Intervention: Drug: Ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
December 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Asim Cheema, MD 416-864-6060 ext 4014 cheemaa@smh.ca
Contact: Payam Dehghani, MD 306-781-7944 payamde@gmail.com
Canada
 
NCT01930591
104
No
Asim Nazir Cheema, St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Prairie Vascular Research Inc. Regina, Saskatchewan, Canada
Principal Investigator: Payam Dehghani, MD Prairie Vascular Research Network, Regina, Saskatchewan
Principal Investigator: Asim Cheema, MD St. Michael's Hospital, Toronto, Ontario
St. Michael's Hospital, Toronto
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP