CClinicalTrials.gg
Not yet recruitingNCT07845903Updated Sep 29, 2026

A Prospective Study to Observe Clinical Outcomes in Patients Receiving Antiplatelet or Anticoagulant Therapy for Cancer-Associated Acute Ischemic Stroke

An observational study in Acute Ischemic Stroke and Cancer, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Xuanwu Hospital, Beijing · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Acute Ischemic Stroke
  • Cancer

Keywords

  • History of Cancer
  • Antiplatelet Therapy
  • Anticoagulant Therapy
  • Antithrombotic Therapy
  • Secondary Stroke Prevention
  • Recurrent Stroke
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

  2. 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.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

  3. 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.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

Secondary outcomes

  1. 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.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

  2. Number of Participants With Venous Thromboembolism

    Venous thromboembolism includes deep vein thrombosis and pulmonary embolism confirmed by an appropriate diagnostic imaging examination.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

  3. 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.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

  4. Number of Participants Who Die From Any Cause

    All-cause mortality is defined as death from any cause occurring during the follow-up period.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

  5. 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.

    Time frame: 30 days, 90 days, 180 days, and 360 days after enrollment

06

Study locations

1 site
  • Xuanwu Hospital, Capital Medical University
    Beijing, Beijing Municipality 100000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845903
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Hongyan Li
Contact
hongyanli@xwhosp.org
+86-18600346925
Chen Zhang
Contact
cherinezhang@163.com
+86-18511551659
Hongyan Li, MD, PhD
principal investigator · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion