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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Ticagrelor
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial.

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Therapeutic platelet inhibition [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Therapeutic platelet inhibition (PRU value <208) at 24±4 hours post PCI.


Other Outcome Measures:
  • MACE [ Time Frame: 24 hours or discharge ] [ Designated as safety issue: Yes ]
    MACE is a composite of death, re-infarction, stroke and bleeding


Estimated Enrollment: 150
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel arm
Clopidogrel 300 mg before PCI followed by 75 mg po OD
Drug: Clopidogrel
300 mg bolus followed by 75 mg OD
Other Name: Plavix
Experimental: Ticagrelor arm
Ticagrelor 180 mg before PCI followed by 90 mg po BID
Drug: Ticagrelor
180 mg bolus followed by 90 mg BID
Other Name: Brilinta

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930591

Contacts
Contact: Asim Cheema, MD 416-864-6060 ext 4014 cheemaa@smh.ca
Contact: Payam Dehghani, MD 306-781-7944 payamde@gmail.com

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Saskatchewan
Prairie Vascular Research Inc. (PVRI), Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Prairie Vascular Research Inc. Regina, Saskatchewan, Canada
Investigators
Principal Investigator: Payam Dehghani, MD Prairie Vascular Research Network, Regina, Saskatchewan
Principal Investigator: Asim Cheema, MD St. Michael's Hospital, Toronto, Ontario
  More Information

No publications provided

Responsible Party: Asim Nazir Cheema, MD, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01930591     History of Changes
Other Study ID Numbers: 104
Study First Received: August 22, 2013
Last Updated: November 6, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
fibrinolytic therapy
stenting
platelet activity

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Ticagrelor
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014