ARAMIS
Problem
Minor non-disabling acute ischaemic stroke
Format
Non-inferiority, multicentre, randomised, open label, blinded endpoint assessment
Treatment
Dual antiplatelet therapy vs. Alteplase
Population
760 patients across 38 centres in China
Inclusion criteria
-
≥18 years
​​
-
Acute ischaemic stroke:
-
NIHSS ≤ 5​
-
NIHSS≤ 1 on vision, language, neglect, single limb weakness
-
NIHSS 0 in consciousness
-
​​
-
Non-disabling symptoms​
​​
-
CT/MRI on admission
​​
-
Treatment within 4.5 hours
​​
-
Informed consent
Exclusion criteria
-
Pre-stroke disability mRS ≥2
​
-
Previous ICH
​
-
Definite indication for anticoagulation
​​
-
CI to thrombolysis
Follow-up
90 days
Primary endpoint
Excellent functional outcome (mRS 0-1) at 90 days
Secondary endpoint(s)
-
Change in NIHSS at 24 hours
​
-
Early neurological improvement at 24 hours
​
-
Early neurological deterioration at 24 hours
​
-
New stroke or vascular event at 90 days
​
-
90-day all-cause mortality
Details
Randomized 1:1. DAPT arm - clopidogrel loading 300mg followed by 75mg OD for 10-14 days with aspirin loading 100mg followed by 100mg OD for 10-14 days followed by single antiplatelet or DAPT based on local guidelines until 90 days.
Alteplase arm - 0.9mg/kg followed by guideline based antiplatelet treatment beginning after 24 hours.
Brief summary
DAPT is non-inferior to alteplase (within 4.5h) in minor stroke in terms of functional outcome at 90 days.
Higher rate of bleeding events in Alteplase group
PAPER: Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke: The ARAMIS Randomized Clinical Trial
Date
27 June 2023
Journal
JAMA
Information
Benefits:
-
DAPT non-inferior to alteplase (within 4.5h) in terms of functional outcome at 90 days
-
Significantly fewer bleeding events in DAPT group
-
Less early neurological deterioration in DAPT group (not due to ICH)
-
No significant difference between 2 groups re other secondary outcomes
Risks:
-
Risk of bleeding events and sICH in both groups, smaller risk in DAPT group
Reference
Chen H, et al. Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke: The ARAMIS Randomized Clinical Trial. JAMA. 2023; 329 (24): 2135-2144. 10.1001/jama.2023.7827.
Content written by Dr Natasha Gibson