Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

Ischemic Stroke Clinical Trial

— AIM-2  

Official title:

Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032053
• Other study ID #: XJLL-KY20212114
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2023
• Source: Xijing Hospital
• Contact: Wen Jiang, Ph.D
• Phone: 86-029-84771319
• Email: jiangwen[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Patients diagnosed clinically as ischemic stroke;

2. Age = 40 years;

3. Onset time = 3 months;

4. Informed consent was signed.

Exclusion Criteria:

1. Patients with symptomatic intracranial hemorrhage;

2. bleeding lesion > 10 mm was found on SWI;

3. Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;

4. There are contraindications for antithrombotic drugs use;

5. Serious systemic diseases;

6. Refusal to sign informed consent or poor compliance.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Ankang Central Hospital	Ankang	Shaanxi
China	3201 Hospital	Hanzhong	Shaanxi
China	Hanzhong People's Hospital	Hanzhong
China	986 Hospital	Xi'An
China	Department of Neurology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi
China	Gaoling District Hospital	Xi'an
China	Gem Flower Xi'an Changqing Staff Hospital	Xi'an
China	Tangdu Hospital	Xi'an
China	The First Affiliated Hospital of Xi'an Medical University	Xi'AN
China	Xi'AN GAOXIN Hospital	Xi'AN	Shannxi
China	No.215 Hospital of Shaanxi nuclear industry	Xianyang
China	The First People's Hospital of Xianyang	Xianyang
China	Xian Yang Central Hospital	Xianyang
China	Yan'an University Affiliated Hospital	Ya'an	Shaanxi
China	Yan'an People's Hospital	Yan'an
China	Yulin No.2 Hospital	Yunlin	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
Xijing Hospital	Ankang Central Hospital, Yan'an University Affiliated Hospital

Country where clinical trial is conducted

China, 

References & Publications (14)

Charidimou A, Boulouis G, Shams S, Calvet D, Shoamanesh A; International META-MICROBLEEDS Initiative. Intracerebral haemorrhage risk in microbleed-positive ischaemic stroke patients with atrial fibrillation: Preliminary meta-analysis of cohorts and anticoagulation decision schema. J Neurol Sci. 2017 Jul 15;378:102-109. doi: 10.1016/j.jns.2017.04.042. Epub 2017 Apr 28. — View Citation

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. — View Citation

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. — View Citation

Gregoire SM, Brown MM, Kallis C, Jager HR, Yousry TA, Werring DJ. MRI detection of new microbleeds in patients with ischemic stroke: five-year cohort follow-up study. Stroke. 2010 Jan;41(1):184-6. doi: 10.1161/STROKEAHA.109.568469. Epub 2009 Nov 5. — View Citation

Kimura K, Aoki J, Shibazaki K, Saji N, Uemura J, Sakamoto Y. New appearance of extraischemic microbleeds on T2*-weighted magnetic resonance imaging 24 hours after tissue-type plasminogen activator administration. Stroke. 2013 Oct;44(10):2776-81. doi: 10.1161/STROKEAHA.113.001778. Epub 2013 Jul 25. — View Citation

Klarenbeek P, van Oostenbrugge RJ, Rouhl RP, Knottnerus IL, Staals J. Higher ambulatory blood pressure relates to new cerebral microbleeds: 2-year follow-up study in lacunar stroke patients. Stroke. 2013 Apr;44(4):978-83. doi: 10.1161/STROKEAHA.111.676619. Epub 2013 Feb 28. — View Citation

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. — View Citation

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. — View Citation

MRI predicts intracranial hemorrhage in patients who receive long-term oral anticoagulation. Neurology. 2019 Sep 3;93(10):465. doi: 10.1212/WNL.0000000000007920. No abstract available. — View Citation

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. — View Citation

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. JAMA Neurol. 2021 Jan 1;78(1):11-20. doi: 10.1001/jamaneurol.2020.3836. Erratum In: JAMA Neurol. 2021 Jan 1;78(1):120. — View Citation

Shoamanesh A, Yan S, Charidimou A. New Cerebral Microbleeds and Mechanism of Post-Thrombolysis Remote Intracerebral Hemorrhage: "Red Meets White" Revisited. Front Neurol. 2015 Sep 15;6:203. doi: 10.3389/fneur.2015.00203. eCollection 2015. No abstract available. — View Citation

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. — View Citation

Wilson D, Ambler G, Shakeshaft C, Brown MM, Charidimou A, Al-Shahi Salman R, Lip GYH, Cohen H, Banerjee G, Houlden H, White MJ, Yousry TA, Harkness K, Flossmann E, Smyth N, Shaw LJ, Warburton E, Muir KW, Jager HR, Werring DJ; CROMIS-2 collaborators. Cerebral microbleeds and intracranial haemorrhage risk in patients anticoagulated for atrial fibrillation after acute ischaemic stroke or transient ischaemic attack (CROMIS-2): a multicentre observational cohort study. Lancet Neurol. 2018 Jun;17(6):539-547. doi: 10.1016/S1474-4422(18)30145-5. Epub 2018 May 16. Erratum In: Lancet Neurol. 2018 Jul;17(7):578. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of cerebral microbleeds	How many cerebral microbleeds increased after 1 year of antithrombotic drugs treatment. The number of microbleeds will be detected by MR-SWI.	1 year after onset
Secondary	Stroke recurrence rate	recurrence rate of ischemic stroke	1 year after onset
Secondary	The incidence of cerebral hemorrhage		1 year after onset