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Blood thinners for stroke survivors with a history of brain bleeding: a delicate balance

NCT ID NCT07609654

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether starting blood thinners (DOACs) is safe and effective for people who have had a stroke, but also have a history of a brain bleed and an irregular heartbeat (atrial fibrillation). About 852 participants will be randomly assigned to receive either a blood thinner or the current standard care (which may include antiplatelet drugs or no blood thinners). The goal is to see which approach better prevents another stroke without causing another brain bleed over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Direct Oral Anticoagulants (DOACs) such as apixaban, rivaroxaban, edoxaban, or dabigatran
What this could lead to
If successful, this could provide clear guidance on whether blood thinners are safe and effective for preventing strokes in patients with both atrial fibrillation and a history of brain bleeding.
What could go wrong
This is a Phase 4 trial, but the population is very high-risk and the balance between preventing clots and causing bleeds is delicate. The results may not apply to all patients, and there is a real risk of recurrent brain bleeding.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 852 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

18 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 ≥ 18 years. 2. Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT). 3. Documented history of spontaneous intracerebral hemorrhage (ICH). 4. Confirmed non-valvular atrial fibrillation (including paroxysmal, persistent, or permanent subtypes). 5. Provision of written informed consent by the patient or a legally authorized representative. Exclusion Criteria: 1. Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score \> 4. 2. Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases. 3. Severe, uncontrolled hypertension refractory to medical therapy. 4. Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) \< 30 mL/min. 5. Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism). 6. Documented contraindications to direct oral anticoagulants according to the product summary of characteristics (excluding the previous spontaneous ICH), including but not limited to hypersensitivity, active clinically significant bleeding, high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk. 7. Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device. 8. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period. 9. Estimated life expectancy of less than 1 year due to concomitant terminal illness.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation intracerebral hemorrhage ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke Atrial fibrillation (AF) Intracerebral hemorrhage

How to take part

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  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

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More trials for these conditions

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