Skip to content

Long-term Dual Antiplatelet Therapy Reduces Intracranial Atherosclerotic Plaque Burden: A Prospective, Multicenter, Open-label, Single-blind, Randomized Controlled Clinical Trial

Long-term Dual Antiplatelet Therapy Reduces Intracranial Atherosclerotic Plaque Burden: A Prospective, Multicenter, Open-label, Single-blind, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095357
Enrollment
Unknown
Registered
2025-01-06
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

DAPT group:Cilostazol 100mg bid + Aspirin 100mg qd / Clopidogrel 75mg qd
SAPT group:Aspirin 100mg qd / Clopidogrel 75mg qd

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with acute ischemic stroke or TIA within 90 days of onset; 2. Age between 18 and 85 years inclusive; 3. Pre-stroke mRS score of 2 or less; 4. Symptomatic intracranial arterial stenosis diagnosed by CTA or MRA (internal carotid artery segments C6-7, anterior cerebral artery segments A1-2, middle cerebral artery segments M1-2, vertebral artery segment V4, basilar artery, posterior cerebral artery segments P1-2), with a stenosis rate of 50% to 99%; 5. Receiving dual antiplatelet therapy with aspirin and clopidogrel, as per the SAMMPRIS study; 6. Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Suspected sources of cardiogenic thrombus, such as paroxysmal atrial fibrillation, infective endocarditis, and post-valve replacement surgery; 2. History of responsible intracranial artery stenting/angioplasty, or planned surgery within 6 months; 3. Concurrent extracranial artery stenosis with a stenosis rate of =50%; 4. Concurrent non-atherosclerotic intracranial arterial diseases, including but not limited to intracranial arterial dissection, moyamoya disease, arteriovenous malformations, aneurysms, vasculitis, etc.; 5. History of intracranial hemorrhage within the past 3 months; 6. Active bleeding disorders, coagulation dysfunction, or other bleeding tendencies; 7. Severe hepatic or renal insufficiency; 8. Any degree of heart failure; 9. Concurrent other severe medical conditions, cognitive or psychiatric disorders that prevent self-care, or life expectancy =3 years; 10. Contraindications to magnetic resonance imaging such as internal metal implants, contrast agent allergies, etc.; 11. Allergy or severe intolerance to the components of the trial medication; 12. Pregnant or lactating women; 13. Assessed by the investigator as unsuitable for this study, or participation in this study would be detrimental; 14. Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Percentage change in plaque burden from baseline to 12 months after onset;

Countries

China

Contacts

Public ContactXin Cheng

Huashan Hospital, Fudan University

chengxin@fudan.edu.cn+86 139 1727 4123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026