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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Antiplatelet Therapy Group
Group B: Anticoagulant Therapy Group
Group C: Combined Antiplatelet and Anticoagulant Therapy Group

Trial outcomes

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

Other outcomes

Sponsors and contacts

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