AzTrials
AzTrials

Ischemic StrokeAIM-2NCT05032053

Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

An observational study of Ischemic Stroke, run by Xijing Hospital at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Antithrombotic drugs
How many people
3,000 participants
Where
16 sitesChina
Study dates
1 Mar 2022to 1 Dec 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wen Jiang, Ph.D contact

86-029-84771319

jiangwen@fmmu.edu.cn

Fang Yang, Ph.D contact

86-029-84771319

fyangx@fmmu.edu.cn

16 sites in 1 country

China16 sites, 16 recruiting

  • Ankang Central Hospital

    Ankang, Shaanxi, 725000

    Xiai Yang, MD

    Xiai Yang, MD

    Recruiting

  • 3201 Hospital

    Hanzhong, Shaanxi

    Hua Li

    Recruiting

  • Hanzhong People's Hospital

    Hanzhong

    Chunrui Zhang

    Recruiting

  • Department of Neurology, Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710032

    Wen Jiang, PhD, 86-029-84771319, jiangwen@fmmu.edu.cn

    Fang Yang, PhD, 86-029-84771319, fyangx@fmmu.edu.cn

    Recruiting

  • Xi'AN GAOXIN Hospital

    Xi'an, Shannxi, 710032

    Yi Jia, 13659283392

    Recruiting

  • 986 Hospital

    Xi'an

    Liyi Chi

    Recruiting

  • Gaoling District Hospital

    Xi'an

    Ning Min

    Recruiting

  • Gem Flower Xi'an Changqing Staff Hospital

    Xi'an

    Chaofeng Zhang

    Recruiting

  • Tangdu Hospital

    Xi'an

    Wei Zhang

    Recruiting

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an

    Bei Zhang

    Recruiting

  • No.215 Hospital of Shaanxi nuclear industry

    Xianyang

    Feng Fu

    Recruiting

  • The First People's Hospital of Xianyang

    Xianyang

    Liping Yu

    Recruiting

  • Xian Yang Central Hospital

    Xianyang

    Jun Wu

    Recruiting

  • Yan'an University Affiliated Hospital

    Ya'an, Shaanxi

    Yidong Xue

    Recruiting

  • Yan'an People's Hospital

    Yan’an

    Baiya Fan

    Recruiting

  • Yulin No.2 Hospital

    Yunlin, Shaanxi, 719000

    Xiaocheng Wang, MD

    Xiaocheng Wang, MD

    Recruiting

Other trials in China

About this study

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.

Read the detailed 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.

Conditions
Ischemic Stroke
Being tested
Antithrombotic drugs
Keywords
Ischemic Stroke, microbleeds, Proteomics, antithrombotic drug
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antithrombotic drugsDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year after onset

Secondary outcomes (2)

  1. Stroke recurrence rate

    recurrence rate of ischemic stroke

    Measured: 1 year after onset

  2. The incidence of cerebral hemorrhage

    Measured: 1 year after onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start1 Mar 2022
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032053
Sponsor's protocol ID
XJLL-KY20212114
Acronym
AIM-2
Status last verified
Jul 2025
First submitted
31 Aug 2021
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29778365

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31616992

  • 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.

    PubMed 28566143

  • 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.

    PubMed 31477619

  • 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.

    PubMed 23887835

  • 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.

    PubMed 26441822

  • 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.

    PubMed 23449261

  • 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.

    PubMed 19892991

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Xijing Hospital at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen Jiang, Ph.D (86-029-84771319, jiangwen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase of cerebral microbleeds (time frame: 1 year after onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032053, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in