Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial.
Stroke Vasc Neurol
; 7(5): 457-461, 2022 10.
Article
en En
| MEDLINE
| ID: mdl-35393360
ABSTRACT
BACKGROUND:
Indobufen can reversibly inhibit platelet aggregation and showed to be effective in the treatment of ischaemic heart and peripheral vascular diseases. However, it is unclear whether indobufen is an alternative antiplatelet agent for treatment of patients with ischaemic stroke.AIM:
To test whether indobufen is non-inferior to aspirin in reducing the risk of new stroke at 3 months in patients with moderate to severe ischaemic stroke.DESIGN:
The Indobufen vs Aspirin in Acute Ischaemic Stroke (INSURE) is a randomised, double-blind, double-dummy, positive drug control, non-inferior multicentre clinical trial conducted in 200 hospitals in China. Participants will be randomised at a 11 ratio to receive either 100 mg indofufen two times daily or 100 mg aspirin once daily within 72 hours of the onset of symptoms from day 1 to 3 months. STUDYOUTCOMES:
The primary efficacy outcome is a new stroke (ischaemic or haemorrhagic) within 3 months and the primary safety outcome is a severe or moderate bleeding event within 3 months.DISCUSSION:
The INSURE trial will evaluate whether indobufen is non-inferior to aspirin in reducing the risk of new stroke at 3 months in patients with moderate to severe ischaemic stroke. TRIAL REGISTRATION NUMBER NCT03871517.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Isquemia Encefálica
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Accidente Cerebrovascular
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Accidente Cerebrovascular Isquémico
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
Límite:
Humans
Idioma:
En
Año:
2022
Tipo del documento:
Article