Acute Ischemic StrokeALLYNCT06058130
Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
A study testing Anticoagulant Oral and Anticoagulation combined with antiplatelet therapy in people with Acute Ischemic Stroke and Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Atrial Fibrillation, Stenosis, Carotid
- What is being tested?
- Anticoagulant Oral and Anticoagulation combined with antiplatelet therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,171 participants
- Where
- 2 sitesChina
- Study dates
- 29 Sep 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 old
- Acute ischemic stroke or TIA with onset < 7 days
- Have a history or newly diagnosed as NVAF
- Concomitant stenosis (>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory
Who cannot join
- Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury
- Have a history or newly diagnosed as valvular heart disease
- Mural thrombus in heart
- Contraindications of anticoagulation or antiplatelet therapy, e.g. severe intracranial hemorrhage
- Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
- Have or plan to receive CEA or CAS in the following 3 months
Show all 10Show fewer
- Life expectancy less than 1 year
- Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
- Pregnant or lactating women
- Individuals identified by researchers as unsuitable for participation in the study due to other reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Min Lou, PhD, loumingxc@vip.sina.com
- Recruiting
Jiaxing Second Hospital
Jiaxing
Xiaoling Zhang
About this study
Official title: Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis
The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.
Read the detailed description
Concomitant NVAF and extracranial/intracranial artery stenosis will greatly increase the risk of stroke, even with standard anticoagulation. However, clinicians may be concerned with the high risk of bleeding complications of anticoagulation combined with antiplatelet therapy. The goal of this clinical trial is to evaluate the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation, Stenosis, Carotid, Intracranial Atherosclerosis
- Being tested
- Anticoagulant Oral, Anticoagulation combined with antiplatelet therapy
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation, Carotid Stenosis, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant OralDrug
Anticoagulation alone
Anticoagulation combined with antiplatelet therapyDrug
Anticoagulation combined with antiplatelet therapy
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation alone | Active comparator | Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily Receives: Drug: Anticoagulant Oral |
| Anticoagulation combined with antiplatelet therapy | Experimental | Rivaroxaban 20mg once daily or 15mg once daily or 10mg once daily / dabigatran 110mg twice daily or 150mg twice daily+ aspirin 100mg once daily / clopidogrel 75mg once daily / ticagrelor 90mg twice daily / cilostazol 100mg twice daily Receives: Drug: Anticoagulation combined with antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 90-day Composite events
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment
Measured: 90 days
Secondary outcomes (9)
The rate of 90-day ischemic stroke
Ischemic stroke within 90 days after enrollment
Measured: 90 days
The rate of 90-day hemorrhagic stroke
Hemorrhagic stroke within 90 days after enrollment
Measured: 90 days
The rate of 90-day myocardial infarction
Myocardial infarction within 90 days after enrollment
Measured: 90 days
The rate of 90-day systemic embolism
Systemic embolism within 90 days after enrollment
Measured: 90 days
The rate of 90-day major extracranial hemorrhage
Major extracranial hemorrhage within 90 days after enrollment
Measured: 90 days
The rate of 90-day non-major bleeding
Non-major bleeding within 90 days after enrollment
Measured: 90 days
The rate of 90-day vascular death
Vascular death within 90 days after enrollment
Measured: 90 days
The rate of 90-day all-cause death
All-cause death within 90 days after enrollment
Measured: 90 days
Discharge modified Rankin scale score
Modified Rankin scale (mRS) at discharge. MRS ranges from 0 to 6, with a higher score indicating worse functional outcome.
Measured: At discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start29 Sep 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,171 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058130
- Sponsor's protocol ID
- ALLY
- Acronym
- ALLY
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis
- ClinicalTrials.gov ID
- NCT06058130
- Acronym / sponsor ID
- ALLY / ALLY
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation, Stenosis, Carotid, Intracranial Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,171 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Sep 2023 (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.
The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.
Detailed description
Concomitant NVAF and extracranial/intracranial artery stenosis will greatly increase the risk of stroke, even with standard anticoagulation. However, clinicians may be concerned with the high risk of bleeding complications of anticoagulation combined with antiplatelet therapy. The goal of this clinical trial is to evaluate the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation alone | Active comparator | Drug: Anticoagulant OralRivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily |
| Anticoagulation combined with antiplatelet therapy | Experimental | Drug: Anticoagulation combined with antiplatelet therapyRivaroxaban 20mg once daily or 15mg once daily or 10mg once daily / dabigatran 110mg twice daily or 150mg twice daily+ aspirin 100mg once daily / clopidogrel 75mg once daily / ticagrelor 90mg twice daily / cilostazol 100mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Acute ischemic stroke or TIA with onset < 7 days
- Have a history or newly diagnosed as NVAF
- Concomitant stenosis (>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory
Key exclusion criteria (10 listed)
- Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury
- Have a history or newly diagnosed as valvular heart disease
- Mural thrombus in heart
- Contraindications of anticoagulation or antiplatelet therapy, e.g. severe intracranial hemorrhage
- Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
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 |
|---|---|---|
| Anticoagulant OralAnticoagulation alone | Drug | Anticoagulation alone |
| Anticoagulation combined with antiplatelet therapyAnticoagulation combined with antiplatelet therapy | Drug | Anticoagulation combined with antiplatelet therapy |
Primary outcome
The rate of 90-day Composite events
Time frame: 90 days
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment
9 secondary outcomes
The rate of 90-day ischemic stroke
Time frame: 90 days
The rate of 90-day hemorrhagic stroke
Time frame: 90 days
The rate of 90-day myocardial infarction
Time frame: 90 days
The rate of 90-day systemic embolism
Time frame: 90 days
The rate of 90-day major extracranial hemorrhage
Time frame: 90 days
The rate of 90-day non-major bleeding
Time frame: 90 days
The rate of 90-day vascular death
Time frame: 90 days
The rate of 90-day all-cause death
Time frame: 90 days
Discharge modified Rankin scale score
Time frame: At discharge, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulant Oral and Anticoagulation combined with antiplatelet therapy in people with Acute Ischemic Stroke and Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD (+8613958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of 90-day Composite events (time frame: 90 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 18 Mar 2024.