Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS)
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|ClinicalTrials.gov Identifier: NCT02869009|
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: clopidogrel Drug: Aspirin||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: clopidogrel plus aspirin group
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.
Other Name: Plavix
Experimental: aspirin group
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.
- Early neurological deterioration assessed as change of NIHSS [ Time Frame: 14 days ]
- 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 ]cerebral hemorrhage，hemorrhage of digestive tract, or moderate to severe bleeding of other organs.
- Total mortality [ Time Frame: 90 days ]
- Adverse events/severe adverse events [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869009
|Contact: Hui-Sheng Chenfirstname.lastname@example.org|
|Contact: Xin-Hong Wangemail@example.com|
|General Hospital of Shenyang Military Region||Recruiting|
|Shenyang, Liaoning, China|
|Contact: Hui-Sheng Chen 86-24-28897511 firstname.lastname@example.org|
|Contact: Xin-hong Wang 86-15309885658 email@example.com|
|Study Director:||Hui-Sheng Chen||General Hospital of Shenyang Military Region|
|Principal Investigator:||Xin-Hong Wang||General Hospital of Shenyang Military Region|