Acute Myocardial InfarctionPhase 3SETFASTNCT01930591
Ticagrelor for PCI Post Thrombolysis
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Acute Myocardial Infarction, run by Unity Health Toronto at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesCanada
- Study dates
- May 2014to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre
London, Ontario, N6A 5W9
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2R2
Prairie Vascular Research Inc. (PVRI), Regina General Hospital
Regina, Saskatchewan, S4P 0W5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: 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.
Read the 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
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- fibrinolytic therapy, stenting, platelet activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
180 mg bolus followed by 90 mg BID
ClopidogrelDrug
Also called Plavix
300 mg bolus followed by 75 mg OD
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel arm | Active comparator | Clopidogrel 300 mg before PCI followed by 75 mg po OD Receives: Drug: Clopidogrel |
| Ticagrelor arm | Experimental | Ticagrelor 180 mg before PCI followed by 90 mg po BID Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic platelet inhibition
Therapeutic platelet inhibition as determined by VerifyNow assay (PRU value <208) at 4±1 hours post PCI
Measured: 4 hours
Secondary outcomes (1)
Therapeutic platelet inhibition
Therapeutic platelet inhibition (PRU value <208) at 24±4 hours post PCI.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Prairie Vascular Research Inc.
- Responsible party
- Sponsor
- Investigators
- Payam Dehghani, MD, Principal investigator, Prairie Vascular Research Network, Regina, SaskatchewanAsim Cheema, MD, Principal investigator, St. Michael's Hospital, Toronto, Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930591
- Sponsor's protocol ID
- 104
- Acronym
- SETFAST
- Status last verified
- Nov 2016
- First submitted
- 22 Aug 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28938956
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial.
- ClinicalTrials.gov ID
- NCT01930591
- Acronym / sponsor ID
- SETFAST / 104
- Conditions
- Acute Myocardial Infarction
- Keywords
- fibrinolytic therapy, stenting, platelet activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Prairie Vascular Research Inc.
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel arm | Active comparator | Drug: ClopidogrelClopidogrel 300 mg before PCI followed by 75 mg po OD |
| Ticagrelor arm | Experimental | Drug: TicagrelorTicagrelor 180 mg before PCI followed by 90 mg po BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: Brilinta180 mg bolus followed by 90 mg BID | Drug | Ticagrelor arm |
| ClopidogrelAlso: Plavix300 mg bolus followed by 75 mg OD | Drug | Clopidogrel arm |
Primary outcome
Therapeutic platelet inhibition
Time frame: 4 hours
Therapeutic platelet inhibition as determined by VerifyNow assay (PRU value <208) at 4±1 hours post PCI
1 secondary outcome
Therapeutic platelet inhibition
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 28938956Dehghani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Payam Dehghani, MD principal investigator
Prairie Vascular Research Network, Regina, Saskatchewan
Asim Cheema, MD principal investigator
St. Michael's Hospital, Toronto, Ontario
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Acute Myocardial Infarction, run by Unity Health Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic platelet inhibition (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.