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New drug combo aims to stop repeat strokes in High-Risk patients

NCT ID NCT07468448

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,172 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.