drugset / Trial / NCT04504864
Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds
Phase 4
Unknown
400 enrolled
Xijing Hospital
Baoji Central Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabShaanxi Provincial People's Hospital · collabTang-Du Hospital · collabThe First Affiliated Hospital of Jiaotong University · collabXi'an Central Hospital · collabXiangyang Central Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2020-10-01
- Primary completion
- 2022-02
- Completion
- 2022-08
Publications
- Background 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.
- Background 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.
- 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.
- 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.
- Background 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.
- Background 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.
- 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.
- 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.
- 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.
- 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.
- Background 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 50 mg | — |
| Subject | Aspirin | Small molecule | 100 mg | — |