Acute Ischemic StrokeNCT07604298
Efficacy and Safety of Indobufen, Aspirin, Cilostazol and Clopidogrel in the Treatment of Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- indubufen, aspirin, clopidogrel, cilostazol
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital,Southern Medical University Recruiting
Guangzhou, Guangdong, 510515
About this study
Official title: Efficacy and Safety of Indobufen, Aspirin, Cilostazol, and Clopidogrel in the Treatment of Ischemic Stroke: a Single-center, Retrospective Study
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.
Read the detailed description
Stroke is the second leading cause of death and the third leading cause of disability worldwide, with a 5%-10% one-year recurrence rate after acute ischemic stroke (AIS), making effective secondary prevention critical. Indobufen, aspirin, clopidogrel, and cilostazol-as monotherapy or in combination-constitute the main antiplatelet strategies for secondary prevention of ischemic stroke. Guidelines recommend early clopidogrel-aspirin dual therapy for mild stroke or TIA, while aspirin remains standard for moderate-to-severe cases, though it carries gastrointestinal and bleeding risks. Clopidogrel may be resistant due to CYP2C19 loss-of-function alleles in Asian populations. Cilostazol may be suitable for patients with CYP2C19-deficiency but has an uncertain intracranial bleeding risk. Indobufen, a reversible COX inhibitor, offers lower bleeding risk and fewer gastrointestinal adverse effects, yet lacks large-scale head-to-head trials against the other agents. Thus, real-world evidence to guide optimal antiplatelet selection for diverse ischemic stroke patients is lacking. This study aims to compare the effectiveness and safety of these four agents (monotherapy or guideline-recommended dual therapy) for secondary prevention of ischemic stroke, providing hypothesis-generating evidence for future prospective research.
- Conditions
- Acute Ischemic Stroke
- Being tested
- indubufen, aspirin, clopidogrel, cilostazol
- Keywords
- Stroke recurrence, Antiplatelet therapy, Secondary prevention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indubufen, aspirin, clopidogrel, cilostazolDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 year of treatment
Secondary outcomes (6)
Incidence of new cardiovascular events and death
any stroke/ myocardial infarction/ cardiovascular death
Measured: Within 1 year
GUSTO-defined bleeding events of all grades
GUSTO-defined bleeding events include intracranial hemorrhage, clinically significant gastrointestinal bleeding, and other specified types of bleeding.
Measured: Within 1 year
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)
Measured: Within 1 year of treatment
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.
Measured: Within 1 year of treatment
Barthel Index
The Barthel Index is a standardized scale widely used to assess patients' activities of daily living (ADL), covering ten basic functional items including feeding, bathing, dressing, toileting, bowel and bladder control, bed-to-chair transfer, walking, and stair climbing. Total scores range from 0 to 100, with higher scores indicating greater independence and better self-care ability. In stroke research, the Barthel Index is commonly used to evaluate neurological recovery and long-term functional outcomes.
Measured: Within 1 year of treatment
Drug-related adverse events
Drug-related adverse events include gastrointestinal discomfort, rash, abnormal liver function, etc.
Measured: Within 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604298
- Sponsor's protocol ID
- NFEC-2026-179
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Indobufen, Aspirin, Cilostazol, and Clopidogrel in the Treatment of Ischemic Stroke: a Single-center, Retrospective Study
- ClinicalTrials.gov ID
- NCT07604298
- Acronym / sponsor ID
- NFEC-2026-179
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke recurrence, Antiplatelet therapy, Secondary prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke is the second leading cause of death and the third leading cause of disability worldwide, with a 5%-10% one-year recurrence rate after acute ischemic stroke (AIS), making effective secondary prevention critical. Indobufen, aspirin, clopidogrel, and cilostazol-as monotherapy or in combination-constitute the main antiplatelet strategies for secondary prevention of ischemic stroke. Guidelines recommend early clopidogrel-aspirin dual therapy for mild stroke or TIA, while aspirin remains standard for moderate-to-severe cases, though it carries gastrointestinal and bleeding risks. Clopidogrel may be resistant due to CYP2C19 loss-of-function alleles in Asian populations. Cilostazol may be suitable for patients with CYP2C19-deficiency but has an uncertain intracranial bleeding risk. Indobufen, a reversible COX inhibitor, offers lower bleeding risk and fewer gastrointestinal adverse effects, yet lacks large-scale head-to-head trials against the other agents. Thus, real-world evidence to guide optimal antiplatelet selection for diverse ischemic stroke patients is lacking. This study aims to compare the effectiveness and safety of these four agents (monotherapy or guideline-recommended dual therapy) for secondary prevention of ischemic stroke, providing hypothesis-generating evidence for future prospective research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indubufen, aspirin, clopidogrel, cilostazolDosage, 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. | Drug | – |
Primary outcome
Incidence of composite events, including any new stroke or bleeding events
Time frame: Within 1 year of treatment
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.
6 secondary outcomes
Incidence of new cardiovascular events and death
Time frame: Within 1 year
GUSTO-defined bleeding events of all grades
Time frame: Within 1 year
National Institutes of Health Stroke Scale (NHISS) score
Time frame: Within 1 year of treatment
Modified Rankin Scale ( mRS ) score
Time frame: Within 1 year of treatment
Barthel Index
Time frame: Within 1 year of treatment
Drug-related adverse events
Time frame: Within 1 year of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Yin (13802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite events, including any new stroke or bleeding events (time frame: Within 1 year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.