Overview
This study aims to evaluate whether long-term dual antiplatelet therapy (DAPT) with cilostazol is associated with a lower risk of recurrent symptomatic ischemic stroke or all-cause mortality compared with single antiplatelet therapy (SAPT) in patients with symptomatic moderate-to-severe intracranial arterial stenosis following the completion of standard DAPT.
Description
Patients with symptomatic intracranial arterial stenosis remain at high risk of recurrent stroke despite standard medical treatment. Although short-term DAPT is recommended, the optimal long-term antiplatelet strategy following standard treatment remains uncertain. Cilostazol-based DAPT may provide additional protection against recurrent ischemic events with an acceptable bleeding risk. Therefore, this real-world cohort study aims to evaluate the effectiveness and safety of long-term cilostazol-based DAPT compared with SAPT in patients with symptomatic moderate-to-severe intracranial arterial stenosis. Treatment strategies are determined according to routine clinical practice rather than assigned by the study protocol.
Eligibility
Inclusion Criteria:
- Age: 18-80 years old.
- Acute mild non-cardioembolic stroke.
- Ischemic stroke or transient ischemic attack (TIA) occurring 2 to 4 weeks prior to enrollment.
- NIHSS score ≤15 at enrollment and pre-stroke mRS score ≤2.
- Ischemic stroke or TIA attributable to the territory of the qualifying intracranial artery.
- Symptomatic 70%-99% intracranial atherosclerotic stenosis confirmed by DSA, CTA, or MRA.
Exclusion Criteria:
- High-risk cardioembolic source requiring or potentially requiring long-term anticoagulation, including persistent or paroxysmal atrial fibrillation, mechanical heart valve or severe valvular disease, intracardiac thrombus, recent myocardial infarction with significant wall-motion abnormality, or severe cardiomyopathy.
- Stroke or TIA caused by nonatherosclerotic disease, including moyamoya disease, vasculitis, arterial dissection, or other definite nonatherosclerotic causes.
- Known allergy or serious adverse reaction to cilostazol, aspirin, clopidogrel, ticagrelor, or other antiplatelet agents.
- Current or previous severe heart failure.
- Severe bleeding event within the previous 6 months, including spontaneous intracranial hemorrhage, major gastrointestinal bleeding, or other bleeding requiring blood transfusion.
- Significant bleeding tendency or coagulation abnormality.
- Medical condition requiring long-term oral anticoagulation.
- Active malignancy or other serious illness with a life expectancy of less than 1 year.
- Severe cognitive impairment or psychiatric illness that would prevent adherence to study treatment or long-term follow-up.
