Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis
NCT ID: NCT06243133
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
1100 participants
INTERVENTIONAL
2024-07-01
2026-03-31
Brief Summary
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whether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.
Participants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.
Researchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dual antiplatelet therapy for 30 days
Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days
clopidogrel for 30 days combined with aspirin for 90 days
Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days
Dual antiplatelet therapy for 90 days
Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days
clopidogrel for 90 days combined with aspirin for 90 days
Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days
Interventions
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clopidogrel for 90 days combined with aspirin for 90 days
Clopidogrel 300mg on the first day, then 75mg/day for 90 consecutive days; Aspirin 100mg/day for 90 days
clopidogrel for 30 days combined with aspirin for 90 days
Clopidogrel 300mg on the first day, then 75mg/ day for 30 consecutive days; Aspirin 100mg/ day for 90 days
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA/CTA/DSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);
3. First stroke onset within 7 days;
4. NIHSS score ≤5;
5. Patients or family members sign informed consent forms;
Exclusion Criteria
2. Patients with recurrent stroke;
3. Patients has undergone major surgery or major trauma within the past 30 days;
4. History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;
5. Contraindications or intolerances to the use of antiplatelet therapeutics;
6. Platelet count \<100\*109/L, hemoglobin\<110g/L;
7. Patients with severe organ insufficiency or other serious disease (e.g., severe cardiopulmonary failure, advanced tumor, severe dementia);
8. Patients intolerant to MRI scan are replaced by CT or DSA;
9. poor compliance, unable to meet the requirements of the study.
40 Years
80 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Nengwei Yu
Head of neurology at Sichuan Provincial People's Hospital
Principal Investigators
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Nengwei Yu, master
Role: STUDY_CHAIR
Sichuan Provincial People's Hospital
Jie Yang, doctor
Role: STUDY_CHAIR
Sichuan Provincial People's Hospital
Locations
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
Wong KS, Chen C, Fu J, Chang HM, Suwanwela NC, Huang YN, Han Z, Tan KS, Ratanakorn D, Chollate P, Zhao Y, Koh A, Hao Q, Markus HS; CLAIR study investigators. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 May;9(5):489-97. doi: 10.1016/S1474-4422(10)70060-0. Epub 2010 Mar 22.
Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.
Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
Other Identifiers
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20223972
Identifier Type: -
Identifier Source: org_study_id
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