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

Ischemic Stroke Clinical Trial

— AIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04504864
• Other study ID #: KY20202059-F-1
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: August 2022

Study information

• Verified date: January 2022
• Source: Xijing Hospital
• Contact: Wen Jiang, Ph.D
• Phone: 86-029-84771319
• Email: jiangwen[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cerebral microbleeds are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Aspirin is the most widely used anti-thrombotic drug in the secondary prevention of patients with non-cardioembolic ischemic stroke. Studies have shown that conventional doses of aspirin can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe anti-thrombotic therapy is still unclear.

The AIM study aims to provide reliable data on the effects of low-dose Aspirin (50mg target recruitment 200) in patients with non-cardioembolic ischemic stroke and cerebral microbleeds compared to conventional dose (100mg target recruitment 200). Patients presenting with acute (<3 weeks) non-cardioembolic ischemic stroke and microbleeds (≧1 microbleeds in SWI scans) will be randomly assigned to the secondary stroke prevention therapy of low-dose or conventional dose aspirin for 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke;

2. Age = 18 years;

3. Onset time = 3 weeks;

4. At least one cerebral microbleeds lesion was found on SWI;

5. Informed consent was signed.

Exclusion Criteria:

1. Patients with symptomatic intracranial hemorrhage;

2. No microbleeds or bleeding lesion > 10 mm was found on SWI;

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

4. Clear anticoagulant indications (such as atrial fibrillation);

5. There are contraindications for aspirin use;

6. The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy;

7. Patients with coronary heart disease or other diseases need to take antiplatelet drugs;

8. Serious systemic diseases;

9. Refusal to sign informed consent or poor compliance.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• low-dose aspirin
50mg aspirin is used to prevent recurrent stroke.
• conventional-does aspirin
100mg aspirin is used to prevent recurrent stroke.

Locations

Country	Name	City	State
China	Baoji Central Hospital	Baoji	Shaanxi
China	Department of Neurology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi
China	Tangdu Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shaanxi
China	Xi'an Central Hospital	Xi'an	Shaanxi
China	Xianyang Central Hospital	Xianyang	Shaanxi

Sponsors (8)

Lead Sponsor	Collaborator
Xijing Hospital	Baoji Central Hospital, Shaanxi Provincial People's Hospital, Tang-Du Hospital, The First Affiliated Hospital of Jiaotong University, The First Affiliated Hospital of Xi'an Medical University, Xi'an Central Hospital, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (14)

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. Erratum in: Transl Stroke Res. 2018 Jan 13;:. — View Citation

Benedictus MR, Prins ND, Goos JD, Scheltens P, Barkhof F, van der Flier WM. Microbleeds, Mortality, and Stroke in Alzheimer Disease: The MISTRAL Study. JAMA Neurol. 2015 May;72(5):539-45. doi: 10.1001/jamaneurol.2015.14. — View Citation

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, Jäger 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. Review. — View Citation

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. — View Citation

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;2 — View Citation

Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. Erratum in: Stroke. 2015 Feb;46(2):e54. — View Citation

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. — View Citation

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. Review. — View Citation

Lau KK, Lovelock CE, Li L, Simoni M, Gutnikov S, Küker 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. 2 — View Citation

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). — View Citation

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. — View Citation

Shoamanesh A, Pearce LA, Bazan C, Catanese L, McClure LA, Sharma M, Marti-Fabregas J, Anderson DC, Kase CS, Hart RG, Benavente OR; SPS3 Trial Investigators. Microbleeds in the Secondary Prevention of Small Subcortical Strokes Trial: Stroke, mortality, and treatment interactions. Ann Neurol. 2017 Aug;82(2):196-207. doi: 10.1002/ana.24988. Epub 2017 Jul 19. — View Citation

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. — View Citation

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, Jäger 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. Epub 2016 Sep 2. — 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 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	Stroke recurrence rate	recurrence rate of ischemic stroke	6 months after onset
Secondary	The incidence of cerebral hemorrhage		6 months after onset