Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

Обзор

To observe the effect of different antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds. And further combined with proteomic methods to explore serological markers that can be used to accurately predict the prognosis of such patients.

Подробное описание

Cerebral microbleeds (CMBs) are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Antithrombotic drug are widely used in the secondary prevention of patients with ischemic stroke. Studies have shown that antithrombotic drug can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe antithrombotic therapy is still unclear.

We will study from two aspects: 1) We designed a cohort registration study to observe the prognosis and progress of CMBs in ischemic stroke patients one year after using various antithrombotic drugs. 2) Data independent acquisition quantitative proteomics (DIA quantitative proteomics) will be used to screen serum protein markers that may affect the prognosis of ischemic stroke patients with CMBs.

Вмешательства

• Препарат Antithrombotic drugs
  The purpose of our study is to observe the effect of various antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds.

Первичные конечные точки

• Increase of cerebral microbleeds [Срок оценки: 1 year after onset]

Вторичные конечные точки (2)

• Stroke recurrence rate [Срок оценки: 1 year after onset]
• The incidence of cerebral hemorrhage [Срок оценки: 1 year after onset]

Критерии участия

Критерии включения

• Patients diagnosed clinically as ischemic stroke;
• Age ≥ 40 years;
• Onset time ≤ 3 months;
• Informed consent was signed.

Критерии исключения

• Patients with symptomatic intracranial hemorrhage;
• bleeding lesion > 10 mm was found on SWI;
• Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
• There are contraindications for antithrombotic drugs use;
• Serious systemic diseases;
• Refusal to sign informed consent or poor compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 16 центров

• Ankang Central Hospital — Ankang
• 3201 Hospital — Hanzhong
• Department of Neurology, Xijing Hospital, Fourth Military Medical University — Сиань
• Yan'an University Affiliated Hospital — Ya'an
• Yulin No.2 Hospital — Yunlin
• Xi'AN GAOXIN Hospital — Сиань
• Hanzhong People's Hospital — Hanzhong
• 986 Hospital — Сиань
• … и ещё 8 центров

Публикации

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• Shoamanesh A, Hart RG, Connolly SJ, Kasner SE, Smith EE, Marti-Fabregas J, Liu YY, Uchiyama S, Mikulik R, Veltkamp R, O'Donnell MJ, Ntaios G, Muir KW, Field TS, Santo GC, Olavarria V, Mundl H, Lutsep H, Berkowitz SD, Sharma M. Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial. PMID 33074284
• Cordonnier C, Al-Shahi Salman R, Wardlaw J. Spontaneous brain microbleeds: systematic review, subgroup analyses and standards for study design and reporting. Brain. 2007 Aug;130(Pt 8):1988-2003. doi: 10.1093/brain/awl387. Epub 2007 Feb 24. PMID 17322562
• Nandigam RN, Viswanathan A, Delgado P, Skehan ME, Smith EE, Rosand J, Greenberg SM, Dickerson BC. MR imaging detection of cerebral microbleeds: effect of susceptibility-weighted imaging, section thickness, and field strength. AJNR Am J Neuroradiol. 2009 Feb;30(2):338-43. doi: 10.3174/ajnr.A1355. Epub 2008 Nov 11. PMID 19001544
• Vernooij MW, Haag MD, van der Lugt A, Hofman A, Krestin GP, Stricker BH, Breteler MM. Use of antithrombotic drugs and the presence of cerebral microbleeds: the Rotterdam Scan Study. Arch Neurol. 2009 Jun;66(6):714-20. doi: 10.1001/archneurol.2009.42. Epub 2009 Apr 13. PMID 19364926
• Liu S, Li C. Antiplatelet Drug Use and Cerebral Microbleeds: A Meta-analysis of Published Studies. J Stroke Cerebrovasc Dis. 2015 Oct;24(10):2236-44. doi: 10.1016/j.jstrokecerebrovasdis.2015.05.022. Epub 2015 Aug 10. PMID 26272868
• Lau KK, Lovelock CE, Li L, Simoni M, Gutnikov S, Kuker W, Mak HKF, Rothwell PM. Antiplatelet Treatment After Transient Ischemic Attack and Ischemic Stroke in Patients With Cerebral Microbleeds in 2 Large Cohorts and an Updated Systematic Review. Stroke. 2018 Jun;49(6):1434-1442. doi: 10.1161/STROKEAHA.117.020104. Epub 2018 May 10. PMID 29748422
• Cheng Y, Wang Y, Song Q, Qiu K, Liu M. Use of anticoagulant therapy and cerebral microbleeds: a systematic review and meta-analysis. J Neurol. 2021 May;268(5):1666-1679. doi: 10.1007/s00415-019-09572-x. Epub 2019 Oct 15. PMID 31616992

Идентификаторы

NCT: NCT05032053 · XJLL-KY20212114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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