Ischemic StrokePhase 4AIMNCT04504864
Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds
A Phase 4 study testing low-dose aspirin and conventional-does aspirin in people with Ischemic Stroke, run by Xijing Hospital at 6 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- low-dose aspirin and conventional-does aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesChina
- Study dates
- 1 Oct 2020to Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Patients with coronary heart disease or other diseases need to take antiplatelet drugs;
- Serious systemic diseases;
- Refusal to sign informed consent or poor compliance.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Baoji Central Hospital
Baoji, Shaanxi
Dong Luo, MD, amosluo@126.com
- 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
Tangdu Hospital
Xi'an, Shaanxi, 710038
Peng Guo, 1443291624@qq.com
Wei Zhang, MD
- Recruiting
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi
Shijun Zhang, MD, 155114434@qq.com
- Recruiting
Xi'an Central Hospital
Xi'an, Shaanxi
Zhiqin Liu, MD, docterqing@163.com
- Recruiting
Xianyang Central Hospital
Xianyang, Shaanxi, 712000
Tao Han, MD, +8615399259050
Changhu Xue, MD
About this study
Official title: Low-dose Aspirin Therapy in Patients With Non-Cardioembolic Ischemic Stroke and Microbleeds
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.
Read the detailed 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.
- Conditions
- Ischemic Stroke
- Being tested
- low-dose aspirin, conventional-does aspirin
- Keywords
- Ischemic Stroke, microbleeds, Clinical trial, Aspirin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose aspirinDrug
50mg aspirin is used to prevent recurrent stroke.
conventional-does aspirinDrug
100mg aspirin is used to prevent recurrent stroke.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: conventional-does aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after onset
Secondary outcomes (2)
Stroke recurrence rate
recurrence rate of ischemic stroke
Measured: 6 months after onset
The incidence of cerebral hemorrhage
Measured: 6 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2020
- Primary completionFeb 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, The First Affiliated Hospital of Jiaotong University, Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xi'an Central Hospital, Xiangyang Central Hospital, Baoji Central Hospital
- Responsible party
- Sponsor
- Investigators
- Wen Jiang, Ph.D, Study director, Department of Neurology, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504864
- Sponsor's protocol ID
- KY20202059-F-1
- Acronym
- AIM
- Status last verified
- Jan 2022
- First submitted
- 5 Aug 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24788967Shoamanesh 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.
PubMed 28681535Kleinig 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.
PubMed 23707603Wilson 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.
PubMed 27590288Benedictus 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.
PubMed 25798556Akhtar 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.
PubMed 29101611Charidimou 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.
PubMed 29338604Charidimou 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.
PubMed 28747441Werring 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.
PubMed 29030477Kim 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.
PubMed 31856691Poels 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.
PubMed 21307170Lau 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.
PubMed 29217662Jia 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.
PubMed 29562586Lau 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Aspirin Therapy in Patients With Non-Cardioembolic Ischemic Stroke and Microbleeds
- ClinicalTrials.gov ID
- NCT04504864
- Acronym / sponsor ID
- AIM / KY20202059-F-1
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, microbleeds, Clinical trial, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, The First Affiliated Hospital of Jiaotong University, Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xi'an Central Hospital, Xiangyang Central Hospital, Baoji Central Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose aspirin | Experimental | Drug: low-dose aspirinManagement 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. |
| conventional-does aspirin | Active comparator | Drug: conventional-does aspirinManagement 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose aspirin50mg aspirin is used to prevent recurrent stroke. | Drug | low-dose aspirin |
| conventional-does aspirin100mg aspirin is used to prevent recurrent stroke. | Drug | conventional-does aspirin |
Primary outcome
Increase of cerebral microbleeds
Time frame: 6 months after onset
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.
2 secondary outcomes
Stroke recurrence rate
Time frame: 6 months after onset
The incidence of cerebral hemorrhage
Time frame: 6 months after onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Background: PubMed 24788967Kernan 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: PubMed 28681535Shoamanesh 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: PubMed 23707603Kleinig 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: PubMed 27590288Wilson 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: PubMed 25798556Benedictus 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: PubMed 29101611Akhtar 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: PubMed 29338604Charidimou 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: PubMed 28747441Charidimou 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: PubMed 29030477Werring 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: PubMed 31856691Kim 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: PubMed 21307170Poels 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 publication: PubMed 29217662Lau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Jiang, Ph.D study director
Department of Neurology, Xijing Hospital, Fourth Military Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low-dose aspirin and conventional-does aspirin in people with Ischemic Stroke, run by Xijing Hospital at 6 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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: 6 months 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 NCT04504864, 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 9 Feb 2022.