Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis: A Real-World Cohort Study (SPDACSIS-COH)
The Secondary Preventive Effect of Long-term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Cerebral Infarction Patients With Symptomatic Moderate to Severe Intracranial Arterial Stenosis: A Real-World Cohort Study (SPDACSIS-COH)
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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Yongjun Cao, M.D, PhD
- Telefonszám: +86 512 67784789
- E-mail: yongjuncao@126.com
Tanulmányi helyek
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-
Jiangsu
-
Suzhou, Jiangsu, Kína, 215004
- Toborzás
- Second Affiliated Hospital of Soochow University
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Kapcsolatba lépni:
- Yongjun Cao, M.D, PhD
- Telefonszám: +86 512 67784789
- E-mail: yongjuncao@126.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Patients with symptomatic intracranial atherosclerotic stenosis who have experienced a recent ischemic stroke or transient ischemic attack and completed 3 months of standard dual antiplatelet therapy. The cohort includes both retrospectively identified historical patients and prospectively enrolled patients who receive cilostazol-based dual antiplatelet therapy or single antiplatelet therapy according to routine clinical practice.
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: OTHER
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
Cilostazol-Based Dual Antiplatelet Therapy
Participants who receive cilostazol 50 mg twice daily in combination with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily for 12 months according to routine clinical practice. |
Participants receive cilostazol 50 mg twice daily in combination with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily according to routine clinical practice. |
|
Single Antiplatelet Therapy
Participants who receive single antiplatelet therapy with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily for 12 months according to routine clinical practice. |
Participants receive single antiplatelet therapy with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily according to routine clinical practice. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Time to First Recurrent Symptomatic Ischemic Stroke or All-Cause Death
Időkeret: From randomization through 12 months
|
Time from Day 90 randomization to the first occurrence of recurrent symptomatic ischemic stroke or death from any cause. |
From randomization through 12 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Incidence of Any Stroke
Időkeret: 12 months
|
Occurrence of any ischemic or hemorrhagic stroke during follow-up. |
12 months
|
|
Incidence of Hemorrhagic Stroke
Időkeret: 12 months
|
Occurrence of symptomatic intracranial hemorrhage or subarachnoid hemorrhage. |
12 months
|
|
Incidence of Ischemic Stroke or Transient Ischemic Attack
Időkeret: Time Frame
|
Occurrence of ischemic stroke or transient ischemic attack during follow-up. |
Time Frame
|
|
Modified Rankin Scale Score
Időkeret: 12 months
|
Functional outcome assessed using the Modified Rankin Scale (mRS), ranging from 0 to 6. A score of 0 indicates no symptoms, whereas a score of 6 indicates death. Higher scores represent greater disability and worse functional outcomes.(0 = no symptoms; 1 = no significant disability despite symptoms; 2 = slight disability, unable to perform all previous activities but able to manage personal affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend to bodily needs without assistance; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; and 6 = death.) |
12 months
|
|
Incidence of All Vascular Events
Időkeret: 12 months
|
Composite vascular events including stroke, myocardial infarction, and other vascular events such as aortic dissection, aortic rupture, pulmonary embolism, hospitalization for heart failure, angina or peripheral artery disease, and coronary, aortic, cervicocephalic, or peripheral arterial revascularization. |
12 months
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Major Bleeding
Időkeret: 12 months
|
Number and proportion of participants who experience bleeding classified as Bleeding Academic Research Consortium (BARC) grade 3 or higher during follow-up. |
12 months
|
|
Incidence of Adverse Events
Időkeret: 12 months
|
Occurrence of any adverse event during the 12-month treatment and follow-up period. |
12 months
|
|
Incidence of Cilostazol-Related Adverse Events Leading to Treatment Discontinuation
Időkeret: 12 months
|
Number and proportion of participants in the cilostazol-based dual antiplatelet therapy group who discontinue cilostazol because of cilostazol-related adverse events, including headache, diarrhea, abnormal stools, palpitations, tachycardia, dizziness, or other adverse reactions considered related to cilostazol. |
12 months
|
Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- LK2026004-COH
- SYW2026005 (Egyéb támogatási/finanszírozási szám: SuZhou Municipal Health Commission)
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