Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds

NCT04504864 | Unknown Phase 4 DMC

• 1 other identifier: KY20202059-F-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to investigate the safety and efficacy of low-dose (50mg) aspirin as a secondary prevention drug in patients with Non-Cardioembolic Ischemic Stroke accompanied by cerebral microbleeds.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; microbleeds; Clinical trial; Aspirin

Outcome Measures

Primary Outcomes (1)

• Increase of cerebral microbleeds

  How many cerebral microbleeds increased after 6 months of aspirin treatment. Cerebral microbleeds will be detected by MR-SWI in the acute stage and 6 months after the onset of stroke.

  6 months after onset

Secondary Outcomes (2)

• Stroke recurrence rate

  6 months after onset

• The incidence of cerebral hemorrhage

  6 months after onset

Study Arms (2)

low-dose aspirin

EXPERIMENTAL

Management policy is to use 50 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 50mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke. But this dose is rarely used clinically, especially in East Asia area.

Drug: low-dose aspirin

conventional-does aspirin

ACTIVE COMPARATOR

Management policy is to use 100 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 100mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke, and this dose is widely used clinically.

Drug: conventional-does aspirin

Interventions

low-dose aspirin DRUG

50mg aspirin is used to prevent recurrent stroke.

low-dose aspirin

conventional-does aspirin DRUG

100mg aspirin is used to prevent recurrent stroke.

conventional-does aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke;
• Age ≥ 18 years;
• Onset time ≤ 3 weeks;
• At least one cerebral microbleeds lesion was found on SWI;
• Informed consent was signed.

You may not qualify if:

• Patients with symptomatic intracranial hemorrhage;
• No microbleeds or bleeding lesion \> 10 mm was found on SWI;
• Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
• Clear anticoagulant indications (such as atrial fibrillation);
• There are contraindications for aspirin use;
• The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy;
• Patients with coronary heart disease or other diseases need to take antiplatelet drugs;
• Serious systemic diseases;
• Refusal to sign informed consent or poor compliance.

Sponsors & Collaborators

• Xijing Hospital: lead
• Shaanxi Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Jiaotong University: collaborator
• Tang-Du Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Xi'an Central Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Baoji Central Hospital: collaborator

Study Sites (6)

Baoji Central Hospital

Baoji, Shaanxi, China

RECRUITING

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, China

RECRUITING

Xi'an Central Hospital

Xi'an, Shaanxi, China

RECRUITING

Xianyang Central Hospital

Xianyang, Shaanxi, 712000, China

RECRUITING

Related Publications (14)

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  PMID: 28681535 BACKGROUND

• Kleinig TJ. Associations and implications of cerebral microbleeds. J Clin Neurosci. 2013 Jul;20(7):919-27. doi: 10.1016/j.jocn.2012.12.002. Epub 2013 May 24.

  PMID: 23707603 BACKGROUND

• Wilson D, Charidimou A, Ambler G, Fox ZV, Gregoire S, Rayson P, Imaizumi T, Fluri F, Naka H, Horstmann S, Veltkamp R, Rothwell PM, Kwa VI, Thijs V, Lee YS, Kim YD, Huang Y, Wong KS, Jager HR, Werring DJ. Recurrent stroke risk and cerebral microbleed burden in ischemic stroke and TIA: A meta-analysis. Neurology. 2016 Oct 4;87(14):1501-1510. doi: 10.1212/WNL.0000000000003183. Epub 2016 Sep 2.

  PMID: 27590288 BACKGROUND

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• Akhtar N, Salam A, Kamran S, D'Souza A, Imam Y, Bermejo PG, Wadiwala MF, Own A, ElSotouhy A, Vattoth S, Bourke P, Bhutta Z, Joseph S, Santos M, Khan RA, Shuaib A. Pre-existing Small Vessel Disease in Patients with Acute Stroke from the Middle East, Southeast Asia, and Philippines. Transl Stroke Res. 2018 Jun;9(3):274-282. doi: 10.1007/s12975-017-0578-7. Epub 2017 Nov 3.

  PMID: 29101611 BACKGROUND

• Charidimou A, Shams S, Romero JR, Ding J, Veltkamp R, Horstmann S, Eiriksdottir G, van Buchem MA, Gudnason V, Himali JJ, Gurol ME, Viswanathan A, Imaizumi T, Vernooij MW, Seshadri S, Greenberg SM, Benavente OR, Launer LJ, Shoamanesh A; International META-MICROBLEEDS Initiative. Clinical significance of cerebral microbleeds on MRI: A comprehensive meta-analysis of risk of intracerebral hemorrhage, ischemic stroke, mortality, and dementia in cohort studies (v1). Int J Stroke. 2018 Jul;13(5):454-468. doi: 10.1177/1747493017751931. Epub 2018 Jan 17.

  PMID: 29338604 BACKGROUND

• Charidimou A, Imaizumi T, Moulin S, Biffi A, Samarasekera N, Yakushiji Y, Peeters A, Vandermeeren Y, Laloux P, Baron JC, Hernandez-Guillamon M, Montaner J, Casolla B, Gregoire SM, Kang DW, Kim JS, Naka H, Smith EE, Viswanathan A, Jager HR, Al-Shahi Salman R, Greenberg SM, Cordonnier C, Werring DJ. Brain hemorrhage recurrence, small vessel disease type, and cerebral microbleeds: A meta-analysis. Neurology. 2017 Aug 22;89(8):820-829. doi: 10.1212/WNL.0000000000004259. Epub 2017 Jul 26.

  PMID: 28747441 BACKGROUND

• Werring DJ, Charidimou A; authors. Response by Werring and Charidimou to Letter Regarding Article, "Microbleeds, Cerebral Hemorrhage, and Functional Outcome After Stroke Thrombolysis: Individual Patient Data Meta-Analysis". Stroke. 2017 Nov;48(11):e332. doi: 10.1161/STROKEAHA.117.019038. Epub 2017 Oct 13. No abstract available.

  PMID: 29030477 BACKGROUND

• Kim BJ, Kwon SU, Park JH, Kim YJ, Hong KS, Wong LKS, Yu S, Hwang YH, Lee JS, Lee J, Rha JH, Heo SH, Ahn SH, Seo WK, Park JM, Lee JH, Kwon JH, Sohn SI, Jung JM, Navarro JC, Kim HY, Kim EG, Kim S, Cha JK, Park MS, Nam HS, Kang DW; PICASSO Investigators. Cilostazol Versus Aspirin in Ischemic Stroke Patients With High-Risk Cerebral Hemorrhage: Subgroup Analysis of the PICASSO Trial. Stroke. 2020 Mar;51(3):931-937. doi: 10.1161/STROKEAHA.119.023855. Epub 2019 Dec 20.

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• Poels MM, Ikram MA, van der Lugt A, Hofman A, Krestin GP, Breteler MM, Vernooij MW. Incidence of cerebral microbleeds in the general population: the Rotterdam Scan Study. Stroke. 2011 Mar;42(3):656-61. doi: 10.1161/STROKEAHA.110.607184. Epub 2011 Feb 9.

  PMID: 21307170 BACKGROUND

• Lau KK, Wong YK, Teo KC, Chang RSK, Tse MY, Hoi CP, Chan CY, Chan OL, Cheung RHK, Wong EKM, Kwan JSK, Hui ES, Mak HKF. Long-Term Prognostic Implications of Cerebral Microbleeds in Chinese Patients With Ischemic Stroke. J Am Heart Assoc. 2017 Dec 7;6(12):e007360. doi: 10.1161/JAHA.117.007360.

  PMID: 29217662 RESULT

• Jia C, Wei C, Hu M, Xu J, Niu K, Zhang C, Lv P, Li L, Dong Y. Correlation between antiplatelet therapy in secondary prevention of acute cerebral infarction and cerebral microbleeds: A susceptibility-weighted imaging (SWI) study. J Xray Sci Technol. 2018;26(4):623-633. doi: 10.3233/XST-17361.

  PMID: 29562586 RESULT

• 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 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Wen Jiang, Ph.D

  Department of Neurology, Xijing Hospital, Fourth Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Wen Jiang, Ph.D

CONTACT

86-029-84771319; jiangwen@fmmu.edu.cn

Fang Yang, Ph.D

CONTACT

86-029-84771319; fyangx@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: October 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)