Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds
AIM-2
1 other identifier
observational
3,000
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedJuly 24, 2025
July 1, 2025
3.8 years
August 31, 2021
July 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Stroke recurrence rate
1 year after onset
The incidence of cerebral hemorrhage
1 year after onset
Interventions
The purpose of our study is to observe the effect of various antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds.
Eligibility Criteria
The population we observed are hospitalized patients with new cerebral infarction and met the inclusion criteria(without exclusion criteria). The method of consecutive participant sampling is used to collect the included population.
You may qualify if:
- Patients diagnosed clinically as ischemic stroke;
- Age ≥ 40 years;
- Onset time ≤ 3 months;
- Informed consent was signed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
- Ankang Central Hospitalcollaborator
- Yan'an University Affiliated Hospitalcollaborator
Study Sites (16)
Ankang Central Hospital
Ankang, Shaanxi, 725000, China
3201 Hospital
Hanzhong, Shaanxi, China
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
Yan'an University Affiliated Hospital
Ya'an, Shaanxi, China
Yulin No.2 Hospital
Yunlin, Shaanxi, 719000, China
Xi'AN GAOXIN Hospital
Xi'an, Shannxi, 710032, China
Hanzhong People's Hospital
Hanzhong, China
986 Hospital
Xi'an, 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
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 People's Hospital
Yan’an, China
Related Publications (14)
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.
PMID: 29778365BACKGROUNDShoamanesh 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.
PMID: 33074284BACKGROUNDCordonnier 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: 17322562BACKGROUNDNandigam 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: 19001544BACKGROUNDVernooij 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: 19364926BACKGROUNDLiu 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: 26272868BACKGROUNDLau 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: 29748422BACKGROUNDCheng 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: 31616992BACKGROUNDCharidimou 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.
PMID: 28566143BACKGROUNDMRI 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.
PMID: 31477619BACKGROUNDKimura 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.
PMID: 23887835BACKGROUNDShoamanesh 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.
PMID: 26441822BACKGROUNDKlarenbeek 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.
PMID: 23449261BACKGROUNDGregoire 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.
PMID: 19892991BACKGROUND
Biospecimen
plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wen Jiang, Ph.D
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 2, 2021
Study Start
March 1, 2022
Primary Completion
December 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share