Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

NCT ID: NCT05032053

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankang Central Hospital

OTHER

Sponsor Role collaborator

Yan'an University Affiliated Hospital

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen Jiang, Ph.D

Role: STUDY_DIRECTOR

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Locations

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Ankang Central Hospital

Ankang, Shaanxi, China

Site Status RECRUITING

3201 Hospital

Hanzhong, Shaanxi, China

Site Status RECRUITING

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Yan'an University Affiliated Hospital

Ya'an, Shaanxi, China

Site Status RECRUITING

Yulin No.2 Hospital

Yunlin, Shaanxi, China

Site Status RECRUITING

Xi'AN GAOXIN Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Hanzhong People's Hospital

Hanzhong, , China

Site Status RECRUITING

986 Hospital

Xi'an, , China

Site Status RECRUITING

Gaoling District Hospital

Xi'an, , China

Site Status RECRUITING

Gem Flower Xi'an Changqing Staff Hospital

Xi'an, , China

Site Status RECRUITING

Tangdu Hospital

Xi'an, , China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Medical University

Xi'an, , China

Site Status RECRUITING

No.215 Hospital of Shaanxi nuclear industry

Xianyang, , China

Site Status RECRUITING

The First People's Hospital of Xianyang

Xianyang, , China

Site Status RECRUITING

Xian Yang Central Hospital

Xianyang, , China

Site Status RECRUITING

Yan'an People's Hospital

Yan’an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen Jiang, Ph.D

Role: CONTACT

86-029-84771319

Fang Yang, Ph.D

Role: CONTACT

86-029-84771319

Facility Contacts

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Xiai Yang, MD

Role: primary

Hua Li

Role: primary

Wen Jiang, PhD

Role: primary

86-029-84771319

Fang Yang, PhD

Role: backup

86-029-84771319

Yidong Xue

Role: primary

Xiaocheng Wang, MD

Role: primary

Yi Jia

Role: primary

13659283392

Chunrui Zhang

Role: primary

Liyi Chi

Role: primary

Ning Min

Role: primary

Chaofeng Zhang

Role: primary

Wei Zhang

Role: primary

Bei Zhang

Role: primary

Feng Fu

Role: primary

Liping Yu

Role: primary

Jun Wu

Role: primary

Baiya Fan

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29778365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33074284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17322562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19001544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19364926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26272868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29748422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31616992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28566143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31477619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23887835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26441822 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 19892991 (View on PubMed)

Other Identifiers

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XJLL-KY20212114

Identifier Type: -

Identifier Source: org_study_id

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