Trial reportCNS drugs2026
Circadian Rhythm and Efficacy of Argatroban in Ischemic Stroke with Alteplase: A Post Hoc Analysis of the ARAIS Trial.
Trial report in CNS drugs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740958 (Argatroban Plus R-tPA for Acute Ischemic Stroke), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
BACKGROUND AND
objectivesThe Argatroban Plus Recombinant Tissue-Type Plasminogen Activator for Acute Ischemic Stroke (ARAIS) trial did not show the benefit of argatroban as an adjunct in patients with acute ischemic stroke who received intravenous alteplase. This post hoc exploratory analysis aimed to determine whether the circadian rhythm can affect the efficacy of argatroban as an adjunct in this population.
methodsFrom the per-protocol population of the ARAIS trial, patients were divided into 2 groups based on the beginning time of intravenous thrombolysis: daytime (06:00-17:59) and nighttime (18:00-05:59) groups. Each group was divided into argatroban plus alteplase and alteplase alone groups. The primary outcome was excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 to 1 at 90 days. The safety outcome was symptomatic intracerebral hemorrhage (sICH).
resultsAmong 692 patients from the per-protocol analysis, 489 were in the daytime group, and 203 in the nighttime group. In the daytime group, the proportion of patients with an excellent functional outcome was 60.5% (144/238) in the argatroban plus alteplase group versus 66.9% (168/251) in the alteplase-alone group, respectively, without significant difference between two groups (adjusted odds ratio [aOR] = 1.19; 95% CI 0.80-1.78; p = 0.40). In the nighttime group, argatroban plus alteplase was significantly associated with higher proportion of excellent functional outcome compared with alteplase alone (75.9% vs 60.3%; aOR = 0.47; 95% CI 0.24-0.93; p = 0.03). An interaction effect was found between intervention (argatroban plus alteplase or alteplase only) by different treatment period on primary outcome (P for interaction = 0.02). For safety outcomes, no significant differences in sICH rates were observed between treatment groups within either time stratum.
conclusionThis is the first report that suggested a potential association between argatroban and a higher rate of excellent functional outcome in patients with acute ischemic stroke who received intravenous alteplase during the nighttime. This finding requires further validation in future studies.
trial registrationClinicalTrials.gov Identifier: NCT03740958.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.