Efficacy and Safety of Indobufen, Aspirin, Cilostazol and Clopidogrel in the Treatment of Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

Through a single-center retrospective cohort study of acute ischemic stroke (AIS) patients receiving secondary prevention with indobufen, clopidogrel, cilostazol, or aspirin as monotherapy or dual therapy, we aim to compare the real-world effectiveness and safety of these four antiplatelet regimens. Through closely tracking the recurrence of stroke (including ischemic and hemorrhagic stroke) and bleeding events (GUSTO-defined) within one year of treatment, we evaluate the association between each antiplatelet agent and the risk of stroke recurrence, thereby providing critical evidence to guide individualized antiplatelet therapy in AIS patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Diagnosed with acute ischemic stroke (AIS) patients according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018 ;

Hospitalized in the Department of Neurology, Nanfang Hospital, Southern Medical University, between January 2020 and December 2025;

Received one of the following as a secondary prevention regimen within 7 days after discharge: indobufen, aspirin, clopidogrel, or cilostazol, either as monotherapy or as dual therapy;

Disqualifiers

Already having long-term anticoagulant therapy at baseline;

History of hemorrhagic stroke or active bleeding;

Severe hepatic or renal dysfunction (defined as AST/ALT > 3 times the upper limit of normal, or estimated glomerular filtration rate < 30 mL/min/1.73m²), end-stage disease, intracranial tumor, or intracranial infection.

Trial population

The study population mainly includes patients who meet the diagnostic criteria for acute ischemic stroke (AIS), are aged over 18 years, hospitalized in the Department of Neurology, Nanfang Hospital, Southern Medical University, between January 2020 and December 2025, received one of the following as a secondary prevention regimen within 7 days after discharge, and have follow-up records at 1 year after treatment initiation. Patients with long-term anticoagulant therapy at baseline, history of hemorrhagic stroke or active bleeding, or severe hepatic or renal dysfunction are excluded.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • indubufen, aspirin, clopidogrel, cilostazol

    Drug

    Dosage, Frequency: Indobufen (200 mg twice daily); Aspirin (100 mg once daily); Cilostazol (100 mg twice daily); Clopidogrel (75 mg once daily). Dual antiplatelet therapy (DAPT) with two of these agents was permitted if clinically indicated, as per the treating physician's judgment.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence of composite events, including any new stroke or bleeding events

Stroke includes any ischemic/hemorrhagic stroke. Bleeding events were defined in accordance with the Global Utilization Of Streptokinase And TPA For Occluded Arteries (GUSTO) definition for bleeding.

Time frame
Within 1 year of treatment

Secondary outcomes

1

Incidence of new cardiovascular events and death

any stroke/ myocardial infarction/ cardiovascular death

Time frame
Within 1 year
2

GUSTO-defined bleeding events of all grades

GUSTO-defined bleeding events include intracranial hemorrhage, clinically significant gastrointestinal bleeding, and other specified types of bleeding.

Time frame
Within 1 year
3

National Institutes of Health Stroke Scale (NHISS) score

The NIHSS score is commonly used to assess the degree of neurological impairment in patients with acute stroke. The NIHSS consists of 11 items, with a total score ranging from 0 to 42. Each item has different scoring criteria, typically ranging from 0 (normal) to 4 (most severe)

Time frame
Within 1 year of treatment
4

Modified Rankin Scale ( mRS ) score

The MRS score is primarily used to measure the degree of disability and daily living ability of patients. The MRS score ranges from 0 to 6, with a total of 7 levels. The higher the score, the more severe the disability and the worse the prognosis.

Time frame
Within 1 year of treatment

Other outcomes

Sponsors and contacts

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