Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke (ARAMIS)
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|ClinicalTrials.gov Identifier: NCT03661411|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 19, 2018
Acute ischemic stroke (AIS) is one of common diseases with significant morbidity, mortality and disability. A wide array of studies confirms that intravenous thrombolytic therapy with alteplase can effectively improve the functional prognosis in acute ischemic stroke. Thus all guidelines recommended the intravenous thrombolytic therapy with alteplase for acute ischemic stroke within 4.5 hours from stroke onset.
Minor stroke is usually defined as NIHSS score ≤ 3 or 5，although it accounts for 1/2-2/3 of AIS, the evidence of thrombolysis is insufficient. A study from Canada shows that 28.5% of patients with minor stroke who have not receive rt-pa thrombolytic therapy are unable to walk independently when discharged. Based on such a consideration,the PRISMS study further compares the efficacy and safety of thrombolytic therapy with antithrombotic therapy in patients with minor stroke. Unfortunately, the study has been early terminated due to the sponsorship reason in 2018, with only 313 cases enrolled. The preliminary results shows that there is no significant difference of the 90-day neurological function between the two groups, while the safety of the treatment group with alteplase has a higher rate of symptomatic intracranial hemorrhage. The patient receiving thrombolysis can not be given antithrombolytic therapy within 24 hours even if the patient's condition has worsened, is clinically more puzzling.
The CHANCE study in 2013 shows that the efficacy of aspirin with clopidogrel is superior to aspirin alone with minor stroke (NIHSS < 3) or TIA(ABCD2 < 4). The POINT study in 2018 further confirmed the efficacy and safety of intensive antithrombotic therapy within 12 hours of onset with minor stroke.
Based on the above discussion, this study aims to explore the efficacy and safety of aspirin with clopidogrel vs alteplase in the treatment of acute minor stroke.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Aspirin Drug: Clopidogrel 75mg Drug: Alteplase||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||760 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study|
|Actual Study Start Date :||October 17, 2018|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Aspirin+ clopidogrel
aspirin 100mg qd and clopidogrel 75mg（300mg in the first day）qd with a total of 10-14 days, then oral aspirin 100mg or clopidogrel 75mg qd lasting for 90 days.
Drug: Clopidogrel 75mg
75mg（after first dose of 300mg）qd
Active Comparator: Alteplase
intravenous alteplase (0.9 mg/kg and maximal dose of 90 mg) was given, and followed by antithrombotic protocol 24 hours after thrombolysis based on clinical guideline.
Iv at 0.9 milligrams per kilogram (mg/kg)
- Proportion of mRS (0-1） [ Time Frame: 90±7 days ]
- Proportion of mRS (0-2） [ Time Frame: 90±7 days ]
- change in NIH Stroke Scale score compared with baseline [ Time Frame: 24 hours ]
- incidence of early neurological improvement [ Time Frame: 24 hours ]more than 2 NIH Stroke Scale score decrease compared with baseline
- Incidence of early neurological deterioration [ Time Frame: 7 days ]more than 2 NIH Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline
- occurrence of stroke or other vascular events [ Time Frame: 90±7 days ]
- proportion of death of any cause [ Time Frame: 90±7 days ]
- occurrence of symptomatic intracranial hemorrhage [ Time Frame: 90±7 days ]more than 4 NIHSS score increase caused by intracranial hemorrhage
- proportion of any bleeding events [ Time Frame: 90±7 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): NCT03661411
|Contact: Xinhong Wang, Doctor||15309885658 ext email@example.com|
|Contact: Yu Cui, Master||18842398646 ext firstname.lastname@example.org|
|Contact: Lin Tao, Master 86-24-28897499|
|Study Chair:||Huisheng Chen, Doctor||Neurology Department|