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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Yongjun Cao, M.D, PhD
- 电话号码：+86 512 67784789
- 邮箱：yongjuncao@126.com
学习地点
-
-
Jiangsu
-
Suzhou、Jiangsu、中国、215004
- 招聘中
- Second Affiliated Hospital of Soochow University
-
接触：
- Yongjun Cao, M.D, PhD
- 电话号码：+86 512 67784789
- 邮箱：yongjuncao@126.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：OTHER
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Recurrent Symptomatic Ischemic Stroke or All-Cause Death
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Any Stroke
大体时间：12 months
|
Occurrence of any ischemic or hemorrhagic stroke during follow-up. |
12 months
|
|
Incidence of Hemorrhagic Stroke
大体时间：12 months
|
Occurrence of symptomatic intracranial hemorrhage or subarachnoid hemorrhage. |
12 months
|
|
Incidence of Ischemic Stroke or Transient Ischemic Attack
大体时间：Time Frame
|
Occurrence of ischemic stroke or transient ischemic attack during follow-up. |
Time Frame
|
|
Modified Rankin Scale Score
大体时间：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
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Major Bleeding
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.