Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND
Stopped: Testing supplies unavailable.
Canada39 participantsStarted 2019-08-22
Plain-language summary
In patients after myocardial infarction (MI) (heart attacks) and treated with percutaneous coronary intervention (PCI), the current standard is dual antiplatelet therapy (DAPT), with aspirin and a P2Y12 receptor inhibitor, for 1 year of treatment. At 1 year, there are several options including: i) Ongoing DAPT (with aspirin and ticagrelor), ii) Selective treatment use of a P2Y12 inhibitor based on risk profiles.
This study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post MI and PCI at 1 year.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>50 years old at 1-year after myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)) during which they had percutaneous coronary intervention (PCI)
* Compliant with dual antiplatelet therapy (DAPT) for ≥ 1 year without an ischemic or bleeding complication after PCI
* Still on DAPT regimen at enrollment
* Patients must have 1 of the following atherothrombotic risk enrichment criteria:
i) Age≥ 65 years ii) Diabetes iii) 2nd Prior MI (\>1 year ago) iv) multi-vessel coronary disease v) creatinine clearance (CrCl) \<60 mL/min.
Exclusion Criteria:
* Intolerance to ticagrelor or clopidogrel
* \>18 months post percutaneous coronary intervention (PCI) and myocardial infarction (MI)
* Requirement of a P2Y12 inhibitor
* Requirement of oral anticoagulation
* Take concurrent CYP3A inducing drugs which may interact with ticagrelor (e.g. anti-epileptic drugs)
* History of stroke, TIA or intracranial bleed
* Recent GI bleed or major surgery
* Life expectancy of \< 1 year
* Platelet count \< 100,000/μl
* Bleeding diathesis
* On dialysis
* Severe liver disease
* At risk for bradycardia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial was terminated before completing, what does that mean for what we actually know about using personalized antiplatelet therapy after a heart attack — is there enough data from it to inform my treatment decisions at all?
2This was a Phase 4 trial studying long-term antiplatelet therapy in people with coronary artery disease or prior heart attack — how does my specific situation compare to the patients who were enrolled, and does that affect whether its findings are relevant to me?
3One of the main things this trial was measuring was a specific type of bleeding risk called BARC bleeding — given that I'd be on long-term antiplatelet therapy, how would you assess my personal bleeding risk versus my risk of another cardiac event?
4Because the trial was terminated and one of its goals was just to test whether enrollment and follow-up was even feasible, does that mean the safety and benefit picture for personalized antiplatelet strategies is still largely unresolved, and what evidence are you using to guide my treatment instead?
5Are there currently other active or completed trials on personalized antiplatelet therapy after myocardial infarction that you'd consider more informative, or would standard guideline-based treatment be a more proven path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bleeding Academic Research Consortium (BARC) Bleeding
Timeframe: 2 years post randomization
2
Feasibility for Patient Enrollment and Follow-up - measured by number of patients enrolled and followed over 2 years
Timeframe: 2 years
Trial details
NCT IDNCT03729401
SponsorOttawa Heart Institute Research Corporation