Ischemic StrokePhase 3ATAMISNCT02869009
Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke
A Phase 3 study testing clopidogrel and Aspirin in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24… 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?
- clopidogrel and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to 31 Oct 2022
- Phase
- Phase 3
- 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
- Age ≥ 18 years
- Acute ischemic stroke that can be randomized within 48 hours of symptoms onset
- neurological deficit: 4 ≤ NIHSS ≤ 10
- CT or MRI scan ruling out hemorrhage or other pathology
- the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1)
- Signed informed consent by patient self or legally authorized representatives
Who cannot join
- intracranial hemorrhage and hemorrhagic cerebral infarction
- Thrombolysis for ischemic stroke
- Allergy to clopidogrel and/or aspirin
- History of stroke with serious sequelae
- Severe systemic disease (such as severe infection, severe hepatic and renal dysfunction)
- Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism)
Show all 16Show fewer
- History of intracranial hemorrhage
- Planned treatment with nonsteroidal anti-inflammatory drugs to affect platelet function
- Anticoagulation within 10 days
- Gastrointestinal bleed or major surgery within 3 months
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
- Planned surgery or intervention to stop antiplatelet therapy
- Ischemic stroke induced by angiography or surgery
- Pregnancy or childbirth within the previous 4 weeks
- Patients who have been treated with any other investigational drug within 3 months of enrollment
- Severe noncardiovascular comorbidity with life expectancy <3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study
The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.
Read the detailed description
The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.
Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.
The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.
- Conditions
- Ischemic Stroke
- Being tested
- clopidogrel, Aspirin
- Keywords
- stroke, clopidogrel, antiplatelets
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Plavix
AspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel plus aspirin group | Experimental | the group will receive a 300mg loading dose of clopidogrel plus aspirin 100 mg, followed by clopidogrel 75 mg/d and aspirin 100 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90. Receives: Drug: clopidogrel; Drug: Aspirin |
| aspirin group | Experimental | the group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early neurological deterioration assessed as change of NIHSS
Measured: 14 days
Secondary outcomes (5)
new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Measured: 90 days
Changes in National Institute of Health stroke scale scores
Measured: 14 days
moderate to severe bleeding events
cerebral hemorrhage，hemorrhage of digestive tract, or moderate to severe bleeding of other organs.
Measured: 14 days
Total mortality
Measured: 90 days
Adverse events/severe adverse events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startNov 2016
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Hui-Sheng Chen, Study director, General Hospital of Shenyang Military RegionXin-Hong Wang, Principal investigator, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869009
- Sponsor's protocol ID
- k2016-06
- Acronym
- ATAMIS
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2016
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
PubMed 23803136Wong KS, Chen C, Fu J, Chang HM, Suwanwela NC, Huang YN, Han Z, Tan KS, Ratanakorn D, Chollate P, Zhao Y, Koh A, Hao Q, Markus HS; CLAIR study investigators. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 May;9(5):489-97. doi: 10.1016/S1474-4422(10)70060-0. Epub 2010 Mar 22.
PubMed 20335070Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.
PubMed 17931979Markus HS, Droste DW, Kaps M, Larrue V, Lees KR, Siebler M, Ringelstein EB. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation. 2005 May 3;111(17):2233-40. doi: 10.1161/01.CIR.0000163561.90680.1C. Epub 2005 Apr 25.
PubMed 15851601Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
PubMed 16531616Diener HC, Bogousslavsky J, Brass LM, Cimminiello C, Csiba L, Kaste M, Leys D, Matias-Guiu J, Rupprecht HJ; MATCH investigators. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet. 2004 Jul 24-30;364(9431):331-7. doi: 10.1016/S0140-6736(04)16721-4.
PubMed 15276392Zhang J, Cui Y, Wang Y, Chen HS. Dual Versus Mono Antiplatelet Therapy in Mild Versus Moderate Ischemic Stroke: A Post Hoc Analysis of the ATAMIS Randomized Trial. Stroke. 2026 Oct 23. doi: 10.1161/STROKEAHA.126.057603. Online ahead of print.
PubMed 42922442Cui Y, Kong XR, Zhang J, Chen HS. Residual early neurological deterioration following dual antiplatelet in stroke: post hoc analysis of the ATAMIS trial. Ther Adv Neurol Disord. 2026 Jun 24;19:17562864261461421. doi: 10.1177/17562864261461421. eCollection 2026.
PubMed 42368889Yan HT, Cui Y, Li ZA, Cai JR, Wang Q, Hou XW, Chen HS. Effect of age on the efficacy and safety of clopidogrel plus aspirin vs aspirin alone in acute mild-to-moderate stroke: a secondary analysis of the ATAMIS trial. Front Neurol. 2025 Oct 27;16:1643517. doi: 10.3389/fneur.2025.1643517. eCollection 2025.
PubMed 41220961Cui Y, Wang YH, Kong XR, Chen HS. Early Neurologic Deterioration and Efficacy of Dual Antiplatelet in Anterior Versus Posterior Circulation Stroke. J Am Heart Assoc. 2025 Feb 4;14(3):e037268. doi: 10.1161/JAHA.124.037268. Epub 2025 Jan 23.
PubMed 39846303Cui Y, Liu QY, Chen HS. Dual Antiplatelet Therapy and Outcomes in Acute Mild to Moderate Stroke With Versus Without Large-Artery Atherosclerosis Post Hoc Analysis of ATAMIS. J Am Heart Assoc. 2024 Sep 17;13(18):e036318. doi: 10.1161/JAHA.124.036318. Epub 2024 Sep 9.
PubMed 39248249Chen HS, Cui Y, Wang XH, Ma YT, Han J, Duan YJ, Lu J, Shen LY, Liang Y, Wang WZ, Wang H, Zhao Y, Zhang JT, Song YL, He XM, Li RH, Tao DB, Li J, Huang SM, Wang N, Hong M, Meng C, Zhang W, Wang DL, Nguyen TN; ATAMIS investigators. Clopidogrel Plus Aspirin vs Aspirin Alone in Patients With Acute Mild to Moderate Stroke: The ATAMIS Randomized Clinical Trial. JAMA Neurol. 2024 May 1;81(5):450-460. doi: 10.1001/jamaneurol.2024.0146.
PubMed 38466274Hou X, Li X, Wang X, Chen H. Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a parallel, randomised, open-label, multicentre, prospective study. Stroke Vasc Neurol. 2018 Sep 23;3(4):263-267. doi: 10.1136/svn-2018-000148. eCollection 2018 Dec.
PubMed 30637134
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT02869009
- Acronym / sponsor ID
- ATAMIS / k2016-06
- Conditions
- Ischemic Stroke
- Keywords
- stroke, clopidogrel, antiplatelets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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 risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.
Detailed description
The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.
Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.
The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel plus aspirin group | Experimental | Drug: clopidogrel, Drug: Aspirinthe group will receive a 300mg loading dose of clopidogrel plus aspirin 100 mg, followed by clopidogrel 75 mg/d and aspirin 100 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90. |
| aspirin group | Experimental | Drug: Aspirinthe group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Acute ischemic stroke that can be randomized within 48 hours of symptoms onset
- neurological deficit: 4 ≤ NIHSS ≤ 10
- CT or MRI scan ruling out hemorrhage or other pathology
- the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1)
Key exclusion criteria (16 listed)
- intracranial hemorrhage and hemorrhagic cerebral infarction
- Thrombolysis for ischemic stroke
- Allergy to clopidogrel and/or aspirin
- History of stroke with serious sequelae
- Severe systemic disease (such as severe infection, severe hepatic and renal dysfunction)
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 |
|---|---|---|
| clopidogrelAlso: Plavix | Drug | clopidogrel plus aspirin group |
| Aspirin | Drug | aspirin group, clopidogrel plus aspirin group |
Primary outcome
Early neurological deterioration assessed as change of NIHSS
Time frame: 14 days
5 secondary outcomes
new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time frame: 90 days
Changes in National Institute of Health stroke scale scores
Time frame: 14 days
moderate to severe bleeding events
Time frame: 14 days
Total mortality
Time frame: 90 days
Adverse events/severe adverse events
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 23803136Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
- Background: PubMed 20335070Wong KS, Chen C, Fu J, Chang HM, Suwanwela NC, Huang YN, Han Z, Tan KS, Ratanakorn D, Chollate P, Zhao Y, Koh A, Hao Q, Markus HS; CLAIR study investigators. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 May;9(5):489-97. doi: 10.1016/S1474-4422(10)70060-0. Epub 2010 Mar 22.
- Background: PubMed 17931979Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.
- Background: PubMed 15851601Markus HS, Droste DW, Kaps M, Larrue V, Lees KR, Siebler M, Ringelstein EB. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation. 2005 May 3;111(17):2233-40. doi: 10.1161/01.CIR.0000163561.90680.1C. Epub 2005 Apr 25.
- Background: PubMed 16531616Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
- Background: PubMed 15276392Diener HC, Bogousslavsky J, Brass LM, Cimminiello C, Csiba L, Kaste M, Leys D, Matias-Guiu J, Rupprecht HJ; MATCH investigators. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet. 2004 Jul 24-30;364(9431):331-7. doi: 10.1016/S0140-6736(04)16721-4.
- Derived from this study: PubMed 42922442Zhang J, Cui Y, Wang Y, Chen HS. Dual Versus Mono Antiplatelet Therapy in Mild Versus Moderate Ischemic Stroke: A Post Hoc Analysis of the ATAMIS Randomized Trial. Stroke. 2026 Oct 23. doi: 10.1161/STROKEAHA.126.057603. Online ahead of print.
- Derived from this study: PubMed 42368889Cui Y, Kong XR, Zhang J, Chen HS. Residual early neurological deterioration following dual antiplatelet in stroke: post hoc analysis of the ATAMIS trial. Ther Adv Neurol Disord. 2026 Jun 24;19:17562864261461421. doi: 10.1177/17562864261461421. eCollection 2026.
- Derived from this study: PubMed 41220961Yan HT, Cui Y, Li ZA, Cai JR, Wang Q, Hou XW, Chen HS. Effect of age on the efficacy and safety of clopidogrel plus aspirin vs aspirin alone in acute mild-to-moderate stroke: a secondary analysis of the ATAMIS trial. Front Neurol. 2025 Oct 27;16:1643517. doi: 10.3389/fneur.2025.1643517. eCollection 2025.
- Derived from this study: PubMed 39846303Cui Y, Wang YH, Kong XR, Chen HS. Early Neurologic Deterioration and Efficacy of Dual Antiplatelet in Anterior Versus Posterior Circulation Stroke. J Am Heart Assoc. 2025 Feb 4;14(3):e037268. doi: 10.1161/JAHA.124.037268. Epub 2025 Jan 23.
- Derived from this study: PubMed 39248249Cui Y, Liu QY, Chen HS. Dual Antiplatelet Therapy and Outcomes in Acute Mild to Moderate Stroke With Versus Without Large-Artery Atherosclerosis Post Hoc Analysis of ATAMIS. J Am Heart Assoc. 2024 Sep 17;13(18):e036318. doi: 10.1161/JAHA.124.036318. Epub 2024 Sep 9.
- Derived from this study: PubMed 38466274Chen HS, Cui Y, Wang XH, Ma YT, Han J, Duan YJ, Lu J, Shen LY, Liang Y, Wang WZ, Wang H, Zhao Y, Zhang JT, Song YL, He XM, Li RH, Tao DB, Li J, Huang SM, Wang N, Hong M, Meng C, Zhang W, Wang DL, Nguyen TN; ATAMIS investigators. Clopidogrel Plus Aspirin vs Aspirin Alone in Patients With Acute Mild to Moderate Stroke: The ATAMIS Randomized Clinical Trial. JAMA Neurol. 2024 May 1;81(5):450-460. doi: 10.1001/jamaneurol.2024.0146.
- 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.
Hui-Sheng Chen study director
General Hospital of Shenyang Military Region
Xin-Hong Wang principal investigator
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clopidogrel and Aspirin in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early neurological deterioration assessed as change of NIHSS (time frame: 14 days). 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 NCT02869009, which also lists 13 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 7 Dec 2022.