Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis (SPDACSIS-RCT)
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 Single-Center, Randomized, Open-Label, Blinded-Endpoint Clinical Trial (SPDACSIS-RCT)
This study aims to evaluate whether long-term dual antiplatelet therapy (DAPT) with cilostazol reduces the 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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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 study aims to evaluate whether long-term cilostazol-based DAPT reduces the risk of recurrent symptomatic ischemic stroke or all-cause mortality compared to SAPT in patients with symptomatic moderate-to-severe intracranial arterial stenosis.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yongjun Cao, M.D, PhD
- 전화번호: +86 512 67784789
- 이메일: yongjuncao@126.com
연구 장소
-
-
Jiangsu
-
Suzhou, Jiangsu, 중국, 215004
- 모병
- Second Affiliated Hospital of Soochow University
-
연락하다:
- Yongjun Cao, M.D, PhD
- 전화번호: +86 512 67784789
- 이메일: yongjuncao@126.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
- Completion of 3 months of standard dual antiplatelet therapy (DAPT).
- Medication adherence ≥80% during the 3 months of standard DAPT.
- High risk for recurrent stroke (defined by at least one prespecified high-risk feature) at the second screening after 3 months of standard DAPT.
- No intracranial endovascular or surgical revascularization within the preceding 3 months.
- No newly developed contraindications to cilostazol-based DAPT or single antiplatelet therapy.
- Signed informed consent by the patient or legally authorized representative.
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Cilostazol-Based Dual Antiplatelet Therapy
Participants will receive cilostazol 50 mg twice daily in combination with one antiplatelet agent: aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily, for 12 months. |
Cilostazol 50 mg twice daily for 12 months. Cilostazol is administered in the experimental arm in combination with one antiplatelet agent: aspirin, clopidogrel, or ticagrelor. Aspirin 100 mg once daily for 12 months. Aspirin may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm. Clopidogrel 75 mg once daily for 12 months. Clopidogrel may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm. Ticagrelor 90 mg twice daily for 12 months. Ticagrelor may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm. |
|
활성 비교기: Single Antiplatelet Therapy
Participants will receive single antiplatelet therapy with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily, for 12 months. |
Aspirin 100 mg once daily for 12 months. Aspirin may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm. Clopidogrel 75 mg once daily for 12 months. Clopidogrel may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm. Ticagrelor 90 mg twice daily for 12 months. Ticagrelor may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to First Recurrent Symptomatic Ischemic Stroke or All-Cause Death
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Any Stroke
기간: 12 months
|
Occurrence of any ischemic or hemorrhagic stroke during follow-up. |
12 months
|
|
Incidence of Hemorrhagic Stroke
기간: 12 months
|
Occurrence of symptomatic intracranial hemorrhage or subarachnoid hemorrhage. |
12 months
|
|
Incidence of Ischemic Stroke or Transient Ischemic Attack
기간: Time Frame
|
Occurrence of ischemic stroke or transient ischemic attack during follow-up. |
Time Frame
|
|
Modified Rankin Scale Score
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major Bleeding
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 뇌혈관 장애
- 뇌 질환
- 중추신경계 질환
- 신경계 질환
- 혈관 질환
- 심혈관 질환
- 뇌졸중
- 허혈성 뇌졸중
- 황 화합물
- 유기 화학 물질
- 피리딘
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- Azoles
- 핵산, 뉴클레오티드 및 뉴 클레오 시드
- 탄화수소
- 탄화수소, 순환
- 탄화수소, 방향족
- 퓨린
- 페놀
- 벤젠 유도체
- 뉴 클레오 시드
- 리보 뉴 클레오 시드
- 퀴놀린
- 티오 펜스
- 살리 실 레이트
- 하이드 록시 벤조이트
- 아데노신
- 퓨린 뉴 클레오 시드
- 테트라 졸
- 티 클로 피딘
- 티오피리딘
- 티카그렐러
- 클로피도그렐
- 실로스타졸
- 아스피린
기타 연구 ID 번호
기타 연구 ID 번호
- LK2026004
- SYW2026005 (기타 보조금/기금 번호: SuZhou Municipal Health Commission)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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