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Clinical study of indobufen versus aspirin in the treatment of arteriosclerotic cerebrovascular disease: A multicenter, double-blind, double simulation, randomized controlled clinical study

Clinical study of indobufen versus aspirin in the treatment of arteriosclerotic cerebrovascular disease: A multicenter, double-blind, double simulation, randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055893
Enrollment
Unknown
Registered
2022-01-22
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Ischemic stroke

Interventions

Experiment group:Treatment of indobufen + aspirin simulator
Control group:Treatment of aspirin + indobufen simulator

Sponsors

Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Over 50 years old; 2.Non acute lacunar infarction confirmed by imaging (axial section diameter less than 15mm), accompanied by at least one of the following signs on MRI: WMH (Fazekas score >= 2); Enlarged perivascular space (PVS); Intracerebral microbleeds (CMBS); 3.Main complaints: dizziness, or unstable posture, or depression, or cognitive decline.

Exclusion criteria

Exclusion criteria: 1.Stenosis of large intra-and extracranial blood vessels; 2.Patients with cognitive impairment or dementia caused by neurodegenerative diseases; 3.Have a history of acute cerebral infarction, symptomatic non-traumatic intracranial hemorrhage or amyloid cerebrovascular disease; 4.Have a history of coagulation disorder, systemic bleeding, thrombocytopenia or neutropenia; 5.Gastrointestinal bleeding occurred within 6 months before randomization; 6.Major surgery was performed within 30 days before randomization; 7.Severe hepatic and renal insufficiency (severe hepatic insufficiency is defined as ALT value > 3 times the upper limit of normal or AST value > 2 times the upper limit of normal; severe renal insufficiency is defined as creatinine > 2 times the upper limit of normal); 8.Have a history of cardiogenic embolism such as atrial fibrillation and atrial myxoma; 9.Diagnosis or proposed diagnosis of acute coronary syndrome; 10.Other antithrombotic treatments are planned for the study period, Including antiplatelet drug therapy (such as open label aspirin, GPIIb / IIIa inhibitor, clopidogrel, tigrel, prasugrel, dipyridamole, Ozagrel, cilostazol, etc.) and anticoagulant drug therapy (such as warfarin, thrombin and factor Xa inhibitor, bivalirudin, hirudin, argatroban, unfractionated heparin and low molecular weight heparin, etc.); 11.Heparin or oral anticoagulants were used within 10 days before randomization; 12.Have a history of drug or food allergy and are known to be allergic to the drug components of this study; 13.Revascularization (any angioplasty or vascular surgery) is planned within 3 months after randomization; 14.Long term (> 7 days) use of NSAIDs is expected during the study; 15.Severe cardiopulmonary disease, and the researcher thinks it is not suitable to participate in this study; 16.Patients with malignant tumors, or patients whose life expectancy is less than 3 months, or patients who are unable to complete the study for other reasons; 17.Women of childbearing age who have negative pregnancy test but refuse to take effective contraceptive measures; Pregnant or lactating women; 18.Participated in other drug or device trials 30 days before randomization; 19.Unable to understand and / or obey the study procedures and / or follow-up due to mental illness.

Design outcomes

Primary

MeasureTime frame
Clinical symptom;Neuropsychological scale;Imaging data;

Countries

China

Contacts

Public ContactXu Yun

Affiliated Drum Tower Hospital of Nanjing University Medical School

xuyun20042001@aliyun.com+86 25 83105208

Outcome results

None listed

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