Acute Ischemic StrokeNCT07845903
A Prospective Study to Observe Clinical Outcomes in Patients Receiving Antiplatelet or Anticoagulant Therapy for Cancer-Associated Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Cancer, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effectiveness and safety of antiplatelet and anticoagulant treatments in people with a history of cancer who have acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Aug 2029
- Phase
- Observational
- 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
Study population: The study population will consist of consecutive adult patients admitted to Xuanwu Hospital and Characteristic Medical Center of Rocket Army with acute ischemic stroke and a history of a malignant tumor. A history of cancer includes both active and inactive cancer. Information on cancer type, stage, metastatic status, time since diagnosis, disease activity, and anticancer treatment will be collected. Antiplatelet, anticoagulant, or combined antithrombotic therapy will be prescribed by the treating physicians according to routine clinical practice and will not be assigned by the study protocol. Participants will be followed to evaluate recurrent stroke, bleeding events, other thromboembolic events, functional outcomes, and mortality.
Who may be able to join
- Age 18 years or older.
- Diagnosis of acute ischemic stroke confirmed by clinical evaluation and brain imaging.
- Enrollment within 7 days after symptom onset or the time the participant was last known to be well.
- History of a malignant tumor, regardless of whether the cancer is currently active or inactive.
- Written informed consent provided by the participant or the participant's legally authorized representative.
Who cannot join
- Hematologic malignancy.
- Primary intracerebral hemorrhage, subarachnoid hemorrhage, or another non-ischemic type of stroke.
- Transient ischemic attack without evidence of acute ischemic stroke.
- Pregnancy or breastfeeding.
- Known severe congenital coagulation disorder.
- Collection of research blood samples would delay intravenous thrombolysis, mechanical thrombectomy, or other necessary treatment.
- Blood samples that do not meet the prespecified collection requirements or show severe hemolysis.
- Inability to obtain reliable medical history or outcome information from the participant, medical records, or an authorized representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Hongyan Li, MD, PhD, +86-18600346925, hongyanli@xwhosp.org
Chen Zhang, MD, PhD, +86-18511551659, cherinezhang@163.com
About this study
Official title: A Prospective Observational Cohort Study Evaluating the Effectiveness and Safety of Antiplatelet and Anticoagulant Therapies in Patients With Active Cancer and Acute Ischemic Stroke
The goal of this observational study is to learn about the effectiveness and safety of antiplatelet and anticoagulant treatments in people with a history of cancer who have acute ischemic stroke. The main questions it aims to answer are:
- Are there differences in the risk of another stroke between people receiving antiplatelet treatment and those receiving anticoagulant treatment?
- Are there differences in the risk of bleeding between the treatment groups?
- Which clinical characteristics, imaging findings, cancer-related factors, and blood test results are associated with treatment outcomes?
Read more
Participants will:
- Receive antiplatelet treatment, anticoagulant treatment, or a combination of both, as selected by their treating physicians during routine clinical care.
- Provide clinical information and blood samples for the study.
- Complete follow-up assessments approximately 30, 90, 180, and 360 days after the stroke.
Researchers will compare recurrent stroke, bleeding, other blood clot-related events, functional recovery, and survival among participants receiving different antithrombotic treatments. The study will not assign or change participants' treatments.
Read the detailed description
The goal of this prospective observational study is to learn about the effectiveness and safety of different antithrombotic treatments in adults with a history of cancer and acute ischemic stroke. The main questions it aims to answer are:
- Are there differences in the risk of recurrent stroke among patients receiving antiplatelet therapy, anticoagulant therapy, or combined therapy?
- Are there differences among the treatment groups in the risk of symptomatic intracranial hemorrhage and major extracranial bleeding?
- Are there differences among the treatment groups in the occurrence of systemic arterial embolism, venous thromboembolism, acute myocardial infarction, disability, and death?
- Which clinical characteristics, stroke mechanisms, neuroimaging findings, cancer-related factors, and laboratory measurements are associated with treatment selection and clinical outcomes?
Participants will:
- Be enrolled within 7 days after the onset of acute ischemic stroke or the last known well time.
- Receive antiplatelet therapy, anticoagulant therapy, or combined therapy as selected by their treating physicians during routine clinical care.
- Provide demographic, clinical, imaging, cancer-related, treatment-related, and laboratory information.
- Provide blood samples for coagulation, platelet, inflammatory, hematologic, biochemical, and other planned assessments.
- Complete follow-up assessments approximately 30, 90, 180, and 360 days after the index stroke.
Researchers will compare the effectiveness and safety outcomes of patients receiving different antithrombotic treatments. The primary effectiveness outcome will be recurrent stroke. The primary safety outcomes will be symptomatic intracranial hemorrhage and major extracranial bleeding. Other outcomes will include systemic arterial embolism, venous thromboembolism, acute myocardial infarction, functional status measured using the modified Rankin Scale, and all-cause mortality.
Patients with either active or inactive cancer may be included. Cancer type, activity, stage, metastatic status, time since diagnosis, and previous or ongoing anticancer treatment will be recorded. Treatment will not be assigned or modified by the study protocol.
- Conditions
- Acute Ischemic Stroke, Cancer
- Keywords
- History of Cancer, Antiplatelet Therapy, Anticoagulant Therapy, Antithrombotic Therapy, Secondary Stroke Prevention, Recurrent Stroke
- Medical subject headings
- Ischemic Stroke, Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet Therapy Group | Patients with acute ischemic stroke and a history of cancer who receive antiplatelet therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol. | |
| Anticoagulant Therapy Group | Patients with acute ischemic stroke and a history of cancer who receive anticoagulant therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol. | |
| Combined Antiplatelet and Anticoagulant Therapy Group | Patients with acute ischemic stroke and a history of cancer who receive combined antiplatelet and anticoagulant therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrent Stroke
Recurrent stroke is defined as a new acute neurological deficit consistent with ischemic or hemorrhagic stroke occurring after enrollment and confirmed by clinical evaluation and brain imaging. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants With Symptomatic Intracranial Hemorrhage
Symptomatic intracranial hemorrhage is defined as a newly detected intracranial hemorrhage on brain imaging that is associated with neurological deterioration or other clinically relevant symptoms. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants With Major Extracranial Bleeding
Major extracranial bleeding includes clinically significant bleeding outside the cranial cavity that results in death, occurs in a critical organ or site, requires blood transfusion, or causes a clinically significant decrease in hemoglobin. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Secondary outcomes (5)
Number of Participants With Systemic Arterial Embolism
Systemic arterial embolism is defined as an acute arterial occlusion outside the central nervous system that is confirmed by clinical evaluation, imaging, surgery, or pathological examination.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants With Venous Thromboembolism
Venous thromboembolism includes deep vein thrombosis and pulmonary embolism confirmed by an appropriate diagnostic imaging examination.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants With Myocardial Infarction
Myocardial infarction will be identified on the basis of clinical symptoms, cardiac biomarkers, electrocardiographic findings, and cardiac imaging, as documented in the medical record.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants Who Die From Any Cause
All-cause mortality is defined as death from any cause occurring during the follow-up period.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Functional Outcome Measured by the Modified Rankin Scale
Functional outcome will be assessed using the modified Rankin Scale. Scores range from 0 to 6, with higher scores indicating greater disability or death. A score of 0 indicates no symptoms, and a score of 6 indicates death.
Measured: 30 days, 90 days, 180 days, and 360 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (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 Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongyan Li, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845903
- Sponsor's protocol ID
- hongyanl2
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study Evaluating the Effectiveness and Safety of Antiplatelet and Anticoagulant Therapies in Patients With Active Cancer and Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07845903
- Acronym / sponsor ID
- hongyanl2
- Conditions
- Acute Ischemic Stroke, Cancer
- Keywords
- History of Cancer, Antiplatelet Therapy, Anticoagulant Therapy, Antithrombotic Therapy, Secondary Stroke Prevention, Recurrent Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 29 Sep 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.
The goal of this observational study is to learn about the effectiveness and safety of antiplatelet and anticoagulant treatments in people with a history of cancer who have acute ischemic stroke. The main questions it aims to answer are:
- Are there differences in the risk of another stroke between people receiving antiplatelet treatment and those receiving anticoagulant treatment?
- Are there differences in the risk of bleeding between the treatment groups?
- Which clinical characteristics, imaging findings, cancer-related factors, and blood test results are associated with treatment outcomes?
Participants will:
- Receive antiplatelet treatment, anticoagulant treatment, or a combination of both, as selected by their treating physicians during routine clinical care.
- Provide clinical information and blood samples for the study.
- Complete follow-up assessments approximately 30, 90, 180, and 360 days after the stroke.
Researchers will compare recurrent stroke, bleeding, other blood clot-related events, functional recovery, and survival among participants receiving different antithrombotic treatments. The study will not assign or change participants' treatments.
Detailed description
The goal of this prospective observational study is to learn about the effectiveness and safety of different antithrombotic treatments in adults with a history of cancer and acute ischemic stroke. The main questions it aims to answer are:
- Are there differences in the risk of recurrent stroke among patients receiving antiplatelet therapy, anticoagulant therapy, or combined therapy?
- Are there differences among the treatment groups in the risk of symptomatic intracranial hemorrhage and major extracranial bleeding?
- Are there differences among the treatment groups in the occurrence of systemic arterial embolism, venous thromboembolism, acute myocardial infarction, disability, and death?
- Which clinical characteristics, stroke mechanisms, neuroimaging findings, cancer-related factors, and laboratory measurements are associated with treatment selection and clinical outcomes?
Participants will:
- Be enrolled within 7 days after the onset of acute ischemic stroke or the last known well time.
- Receive antiplatelet therapy, anticoagulant therapy, or combined therapy as selected by their treating physicians during routine clinical care.
- Provide demographic, clinical, imaging, cancer-related, treatment-related, and laboratory information.
- Provide blood samples for coagulation, platelet, inflammatory, hematologic, biochemical, and other planned assessments.
- Complete follow-up assessments approximately 30, 90, 180, and 360 days after the index stroke.
Researchers will compare the effectiveness and safety outcomes of patients receiving different antithrombotic treatments. The primary effectiveness outcome will be recurrent stroke. The primary safety outcomes will be symptomatic intracranial hemorrhage and major extracranial bleeding. Other outcomes will include systemic arterial embolism, venous thromboembolism, acute myocardial infarction, functional status measured using the modified Rankin Scale, and all-cause mortality.
Patients with either active or inactive cancer may be included. Cancer type, activity, stage, metastatic status, time since diagnosis, and previous or ongoing anticancer treatment will be recorded. Treatment will not be assigned or modified by the study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet Therapy Group | – | –Patients with acute ischemic stroke and a history of cancer who receive antiplatelet therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol. |
| Anticoagulant Therapy Group | – | –Patients with acute ischemic stroke and a history of cancer who receive anticoagulant therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol. |
| Combined Antiplatelet and Anticoagulant Therapy Group | – | –Patients with acute ischemic stroke and a history of cancer who receive combined antiplatelet and anticoagulant therapy for secondary stroke prevention. The treatment regimen is determined by the treating physician as part of routine clinical care and is not assigned by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of consecutive adult patients admitted to Xuanwu Hospital and Characteristic Medical Center of Rocket Army with acute ischemic stroke and a history of a malignant tumor. A history of cancer includes both active and inactive cancer. Information on cancer type, stage, metastatic status, time since diagnosis, disease activity, and anticancer treatment will be collected. Antiplatelet, anticoagulant, or combined antithrombotic therapy will be prescribed by the treating physicians according to routine clinical practice and will not be assigned by the study protocol. Participants will be followed to evaluate recurrent stroke, bleeding events, other thromboembolic events, functional outcomes, and mortality.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Diagnosis of acute ischemic stroke confirmed by clinical evaluation and brain imaging.
- Enrollment within 7 days after symptom onset or the time the participant was last known to be well.
- History of a malignant tumor, regardless of whether the cancer is currently active or inactive.
- Written informed consent provided by the participant or the participant's legally authorized representative.
Key exclusion criteria (8 listed)
- Hematologic malignancy.
- Primary intracerebral hemorrhage, subarachnoid hemorrhage, or another non-ischemic type of stroke.
- Transient ischemic attack without evidence of acute ischemic stroke.
- Pregnancy or breastfeeding.
- Known severe congenital coagulation disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Recurrent Stroke
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Recurrent stroke is defined as a new acute neurological deficit consistent with ischemic or hemorrhagic stroke occurring after enrollment and confirmed by clinical evaluation and brain imaging. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Number of Participants With Symptomatic Intracranial Hemorrhage
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Symptomatic intracranial hemorrhage is defined as a newly detected intracranial hemorrhage on brain imaging that is associated with neurological deterioration or other clinically relevant symptoms. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
Number of Participants With Major Extracranial Bleeding
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Major extracranial bleeding includes clinically significant bleeding outside the cranial cavity that results in death, occurs in a critical organ or site, requires blood transfusion, or causes a clinically significant decrease in hemoglobin. Events will be assessed during follow-up visits at 30, 90, 180, and 360 days.
5 secondary outcomes
Number of Participants With Systemic Arterial Embolism
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants With Venous Thromboembolism
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants With Myocardial Infarction
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Number of Participants Who Die From Any Cause
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
Functional Outcome Measured by the Modified Rankin Scale
Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment
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 29 Sep 2026.
- 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.
Hongyan Li, MD, PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Cancer, run by Xuanwu Hospital, Beijing at 1 site 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 5 inclusion and 8 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Hongyan Li (+86-18600346925, hongyanli@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Recurrent Stroke (time frame: 30 days, 90 days, 180 days, and 360 days after enrollment). The study lists 3 primary outcomes in all. 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 29 Sep 2026.