Stroke, Ischemic study: Edoxaban vs Aspirin or clopidogrel
Official title Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial
ClinicalTrials.gov ID: NCT07454707
What this study is testing
What is Edoxaban 15 mg?
An investigational once‑daily oral tablet being studied for secondary stroke prevention in older patients without atrial fibrillation. It is designed to inhibit the coagulation protein Factor Xa to reduce blood clot formation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether adding 15 mg of the anticoagulant edoxaban to standard antiplatelet therapy reduces the chance of another stroke, serious strokes, heart attacks, or dementia, and how often bleeding occurs.
- Who it's for
- Older adults (age 75 and older) who have already had a stroke and are taking aspirin or clopidogrel.
- What's involved
- Participants are randomly assigned to take either the extra 15 mg edoxaban tablet daily or just their usual antiplatelet drug. They get a phone check‑in every three months and yearly visits for questionnaires about symptoms, memory, and quality of life.
- Time commitment
- The study lasts about 2 to 4 years, with quarterly phone calls and yearly in‑person visits at the start, middle, and end of the study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- Age ≥75 years on the day of informed consent.
- Diagnosis of an acute ischemic stroke within the preceding 12 months, which was clinically symptomatic and confirmed by neuroimaging (CT or MRI), and...
- The patient has had ECG monitoring after the qualifying stroke event (Holter, telemetry, or other continuous ECG monitoring device) totalling at...
- Written informed consent from participant or legally authorized representative.
You likely can't join if
- Diagnosis of atrial fibrillation or atrial flutter (AF) documented in the patient's medical history or examination; any AF on a 12-lead ECG
- Any of the following 'major-risk' cardiac sources of embolism based on the patient's medical history and post-stroke echocardiography (transthoracic...
- The patient has a medical requirement for chronic anticoagulant therapy or dual antiplatelet therapy, or dual or triple antithrombotic therapy (e.g.
- The qualifying stroke etiology is attributed to vasculitis, arterial dissection, migraine, vasospasm, drug abuse, infective endocarditis...
- History of gastrointestinal bleeding or another major bleeding event within the past 12 months
- Hepatic disease associated with coagulopathy; acute hepatitis; chronic active hepatitis; severe hepatic disease (Child-Pugh class C); or cirrhosis.
See the full eligibility criteria
- Age ≥75 years on the day of informed consent.
- Diagnosis of an acute ischemic stroke within the preceding 12 months, which was clinically symptomatic and confirmed by neuroimaging (CT or MRI), and for which the treatment plan is single antiplatelet therapy with...
- The patient has had ECG monitoring after the qualifying stroke event (Holter, telemetry, or other continuous ECG monitoring device) totalling at least 24 hours and with no episodes of atrial fibrillation (or atrial...
- Written informed consent from participant or legally authorized representative.
- Diagnosis of atrial fibrillation or atrial flutter (AF) documented in the patient's medical history or examination; any AF on a 12-lead ECG; or any episode of AF ≥6 minutes on a Holter or other continuous ECG monitor.
- Any of the following 'major-risk' cardiac sources of embolism based on the patient's medical history and post-stroke echocardiography (transthoracic or transesophageal) or other cardiac imaging within the past 12...
- The patient has a medical requirement for chronic anticoagulant therapy or dual antiplatelet therapy, or dual or triple antithrombotic therapy (e.g.
- The qualifying stroke etiology is attributed to vasculitis, arterial dissection, migraine, vasospasm, drug abuse, infective endocarditis, antiphospholipid antibody syndrome or other high-risk thrombophilia; Moya Moya
- History of gastrointestinal bleeding or another major bleeding event within the past 12 months; active or recent spontaneous non-trivial bleeding (within the past 30 days); unresolved peptic ulcer
- Hepatic disease associated with coagulopathy; acute hepatitis; chronic active hepatitis; severe hepatic disease (Child-Pugh class C); or cirrhosis.
- Receiving hemodialysis or peritoneal dialysis, or dialysis is planned within the next 12 months.
- History of CT-detected intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma).
- Uncontrolled hypertension (BP persistently \>160 mmHg systolic or \>100 mmHg diastolic) within the past 7 days before informed consent.
- calculated creatinine clearance \<30 mL/min (Cockroft Gault);
- platelet count \<100 x 109/L;
- hemoglobin \<100 g/L;
- INR \>1.3
- Body weight \<45 kg.
- Any anticoagulant drug. This includes unfractionated heparin (UFH); any low molecular weight heparin (LMWH) (e.g.
- Any antiplatelet medication other than aspirin 80 or 81 mg daily or clopidogrel 75 mg daily. This includes ticagrelor (Brillinta), prasugrel (Effient), dipyridamole, aspirin/extended-release dipyridamole (Aggrenox)...
- Dual antiplatelet therapy; or
- Daily nonsteroidal anti-inflammatory drug (NSAID) use; or
- Drugs expected to increase edoxaban concentration: cyclosporine, tacrolimus, quinidine, dronedarone, erythromycin, ketoconazole, itraconazole, HIV protease inhibitors (ritonavir, darunavir, atazanivir, and others)...
- Drugs expected to decrease edoxaban concentration: carbamazepine, phenytoin, phenobarbital, primidone, valproic acid, rifampin/rifampicin, St. John's wort.
- Total disability and dependence (modified Rankin scale score=5 at time of informed consent).
- The patient is likely to be poorly compliant or unreliable with medication intake or study follow-up appointments, or estimated life expectancy is \<1 year due to severe stroke, concomitant disease, or terminal illness.
- Known allergy/hypersensitivity to edoxaban or other contraindication to edoxaban.
- Any other condition that in the opinion of the enrolling physician would not permit the addition of edoxaban 15 mg once-daily to single antiplatelet therapy.
- Enrolment in another clinical trial involving a drug intervention, or enrolment in another clinical trial involving a non-drug intervention for stroke prevention or cardiovascular prevention.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.