StrokePhase 3NCT07746882
Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy
A Phase 3 study testing Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran and Aspirin in people with Stroke and Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic Stroke
- What is being tested?
- Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 30 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Ischemic stroke patients with undetermined etiology, within 14 days of onset, with completed etiological assessment
- At least one of the following:
- Cortical or multi-territorial infarct
- Recurrent stroke or stroke on antiplatelet therapy
- Left atrial diameter >40 mm
- Left ventricular dysfunction (EF 30-40% or regional wall motion abnormality)
- Atrial premature beats >1500/24h
Who cannot join
- Stenosis ≥50% in the responsible vessel or high-risk plaque
- Identified cardioembolic source
- PFO with planned closure
- Malignancy
- Indication for mandatory anticoagulation/antiplatelet therapy
- Active bleeding (intracranial, subarachnoid, gastrointestinal, etc.)
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- History of intracranial hemorrhage
- Current or recent gastrointestinal ulcer
- Recent brain or spinal injury/surgery
- Known or suspected vascular malformations or aneurysms
- Severe renal impairment (CrCl <30 ml/min)
- Liver disease with bleeding risk (Child-Pugh B or C)
- Pregnancy or lactation
- Other contraindications to anticoagulation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.
- Conditions
- Stroke, Acute Ischemic Stroke
- Being tested
- Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran, Aspirin
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban, or Edoxaban , or Apixaban , or DabigatranDrug
Also called Anticoagulation Therapy
Rivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily
AspirinDrug
Also called Anti-platelet therapy
Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation Group | Experimental | Rivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily Receives: Drug: Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran |
| Anti-platelet Group | Other | Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month ischemic stroke recurrence
Recurrent ischemic stroke within 3 months.
Measured: 90 ± 7 days
Secondary outcomes (6)
3-month Composite vascular event
Composite of ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial bleeding, and vascular death within 3 months
Measured: 90 ± 7 days
Presence of intracerebral hemorrhage (ICH) evaluated by CT or MRI
the presence of ICH is defined according the standard from ECASS-2 study
Measured: 90 ± 7 days
Presence of myocardial infarction within 3 months
Presence of myocardial infarction within 3 months
Measured: 90 ± 7 days
Presence of major extracranial bleeding within 3 months
Presence of major extracranial bleeding within 3 months
Measured: 90 ± 7 days
Presence of vascular death within 3 months
Hospitalization records or follow-up results
Measured: 90 ± 7 days
3-month mortality
Hospitalization records or follow-up results
Measured: 90 ± 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Lou, PhD, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746882
- Sponsor's protocol ID
- PACS
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting the privacy of participants is a priority, and sharing IPD could potentially compromise this.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy
- ClinicalTrials.gov ID
- NCT07746882
- Acronym / sponsor ID
- PACS
- Conditions
- Stroke, Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation Group | Experimental | Drug: Rivaroxaban, or Edoxaban , or Apixaban , or DabigatranRivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily |
| Anti-platelet Group | Other | Drug: AspirinAspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Ischemic stroke patients with undetermined etiology, within 14 days of onset, with completed etiological assessment
- At least one of the following:
Key exclusion criteria (14 listed)
- Stenosis ≥50% in the responsible vessel or high-risk plaque
- Identified cardioembolic source
- PFO with planned closure
- Malignancy
- Indication for mandatory anticoagulation/antiplatelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban, or Edoxaban , or Apixaban , or DabigatranAlso: Anticoagulation TherapyRivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily | Drug | Anticoagulation Group |
| AspirinAlso: Anti-platelet therapyAspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable | Drug | Anti-platelet Group |
Primary outcome
3-month ischemic stroke recurrence
Time frame: 90 ± 7 days
Recurrent ischemic stroke within 3 months.
6 secondary outcomes
3-month Composite vascular event
Time frame: 90 ± 7 days
Presence of intracerebral hemorrhage (ICH) evaluated by CT or MRI
Time frame: 90 ± 7 days
Presence of myocardial infarction within 3 months
Time frame: 90 ± 7 days
Presence of major extracranial bleeding within 3 months
Time frame: 90 ± 7 days
Presence of vascular death within 3 months
Time frame: 90 ± 7 days
3-month mortality
Time frame: 90 ± 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Protecting the privacy of participants is a priority, and sharing IPD could potentially compromise this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Lou, PhD, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran and Aspirin in people with Stroke and Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD, MD (8613958007213, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month ischemic stroke recurrence (time frame: 90 ± 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.