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New drug combo aims to stop repeat strokes in High-Risk patients
NCT ID NCT07468448
First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This phase 3 trial will test whether a low dose of the blood thinner rivaroxaban plus aspirin can prevent recurrent strokes better than the standard clopidogrel plus aspirin in people with narrowed brain arteries. About 1,172 participants who recently had a stroke or high-risk TIA will be followed for up to 90 days on the study drugs, then on aspirin alone. The goal is to see if the rivaroxaban combo reduces the chance of another stroke.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rivaroxaban (a blood thinner) plus aspirin
- What this could lead to
- If it works, this could offer a more effective way to prevent repeat strokes in people with narrowed brain arteries.
- What could go wrong
- This is a large phase 3 trial, but it hasn't started yet. The combination may increase bleeding risk, and results may not apply to all stroke patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,172 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \> 40 years 2. Ischemic stroke or high-risk TIA (motor and/ or speech involvement) 3. Randomization within 30 days of index stroke 4. Stroke potentially attributable to ICAS 30-99% (or flow gap on time-offlight MRA) of a major intracranial artery (internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, intracranial vertebral artery, or basilar artery) by MRA or CTA or catheter angiography. 5. Modified Rankin Scale Score \< 4 at randomization 6. Ability to obtain informed consent prior to randomization. Exclusion Criteria: 1. Cardioembolic stroke 2. Indication for long-term dual antiplatelet or anticoagulant therapy (e.g. venous thromboembolism, coronary stent, mechanical prosthetic valve) 3. Intracranial arterial stenosis secondary to causes other than atherosclerosis e.g. dissection, moya moya disease 4. Substantial extracranial carotid artery disease ipsilateral to the qualifying stroke with plans for carotid revascularization 5. Intended intracranial stenting for the qualifying stroke 6. Symptomatic hemorrhagic transformation of the index stroke, or neuroradiological class 2 (PH2 type) or symptomatic class 3 on Heidelberg scale prior to randomization 7. Previous non-traumatic intracerebral hemorrhage, non-aneurysmal subarachnoid hemorrhage (treated aneurysmal subarachnoid hemorrhage will be allowed) 8. Subdural hematoma within 12 months prior to randomization or traumatic brain hemorrhage within 1 month prior to randomization 9. Advanced kidney disease at randomization (eGFR \<15 ml per minute) 10. Platelet count less than 100,000/mm3 at enrolment or other bleeding diatheses 11. Uncontrolled hypertension with BP consistently above 180 mmHg for systolic and 110mmHg for diastolic while on treatment 12. Known hypersensitivity or contraindication to ASA, clopidogrel or rivaroxaban 13. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) or P- glycoprotein (P-gp) 14. Females of childbearing potential who are not surgically sterile, pregnant, or breast-feeding 15. Previous randomization to this study 16. Participating in a study with an investigational drug or medical device that would interfere with the study at the time of randomization (participants that are no longer in an active arm of a study but are being followed may be randomized) 17. Terminal medical illness with life expectancy less than 1 year
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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