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

NCT07845903 | Not Yet Recruiting DMC

• 1 other identifier: hongyanl2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke; Cancer

Keywords

History of Cancer; Antiplatelet Therapy; Anticoagulant Therapy; Antithrombotic Therapy; Secondary Stroke Prevention; Recurrent Stroke

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  30 days, 90 days, 180 days, and 360 days after enrollment

Secondary Outcomes (5)

• Number of Participants With Systemic Arterial Embolism

  30 days, 90 days, 180 days, and 360 days after enrollment

• Number of Participants With Venous Thromboembolism

  30 days, 90 days, 180 days, and 360 days after enrollment

• Number of Participants With Myocardial Infarction

  30 days, 90 days, 180 days, and 360 days after enrollment

• Number of Participants Who Die From Any Cause

  30 days, 90 days, 180 days, and 360 days after enrollment

• Functional Outcome Measured by the Modified Rankin Scale

  30 days, 90 days, 180 days, and 360 days after enrollment

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and thrombus tissue retrieved during mechanical thrombectomy, when available.

MeSH Terms

Conditions

Ischemic Stroke; Neoplasms; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hongyan Li, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongyan Li

CONTACT

+86-18600346925; hongyanli@xwhosp.org

Chen Zhang

CONTACT

+86-18511551659; cherinezhang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)