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

NCT07604298 | Not Yet Recruiting

• 1 other identifier: NFEC-2026-179
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke recurrence; Antiplatelet therapy; Secondary prevention

Outcome Measures

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.

  Within 1 year of treatment

Secondary Outcomes (6)

• Incidence of new cardiovascular events and death

  Within 1 year

• GUSTO-defined bleeding events of all grades

  Within 1 year

• National Institutes of Health Stroke Scale (NHISS) score

  Within 1 year of treatment

• Modified Rankin Scale ( mRS ) score

  Within 1 year of treatment

• Barthel Index

  Within 1 year of treatment

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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;
• Have follow-up records at 1 year after treatment initiation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital,Southern Medical University Recruiting

Guangzhou, Guangdong, 510515, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; Clopidogrel; Cilostazol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetrazoles; Azoles; Quinolines

Central Study Contacts

Jia Yin

CONTACT

13802964883; jiajiayin@139.com

Jiayin Chen

CONTACT

13337523808; liuqiruismu@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)