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NCT03433235
Early Administration of Edoxaban After Acute Ischemic Stroke in Patients With Non-valvular Atrial Fibrillation
Phase 2 trial testing Edoxaban in Acute Ischemic Stroke in 68 participants. Completed in 2 July 2020.
14 April 2020
Quick facts
| Lead sponsor | Jong Sung Kim |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 68 |
| Start date | 19 June 2018 |
| Primary completion | 14 April 2020 |
| Estimated completion | 2 July 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Edoxaban (edoxaban) — full drug profile →
Conditions studied
- Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →
Sponsor
Jong Sung Kim
Who can join
20 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators hypothesize that earlier initiation of edoxaban in AF-related stroke patients may significantly reduce the early recurrence of ischemic stroke, compared with conventional strategy of anticoagulation following 1-3-6-12 rule. To expedite the verification of the hypothesis, the investigators are planning to use diffusion weighted imaging (DWI), which has been reported to be a surrogate to predict both short-term and long-term prognosis after stroke, to detect the recurrent ischemic events. Because data on the early anticoagulation in patients with AF-related stroke are limited, the investigators decided to perform a pilot study before establishing an appropriate clinical trial protocol. This study will help estimate the efficacy and safety of early administration of edoxaban, and determine the sample size of a following clinical trial. To ensure the safety in this pilot exploration, the investigators will not include patients with severe ischemic strokes, who are often prone to experience hemorrhagic transformation in the acute post-stroke period.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Update of Anticoagulation Use in Cardioembolic Stroke With a Special Reference to Endovascular Treatment.
Safouris A, Psychogios K, Palaiodimou L, Orosz P, et al · · 2024 · cited 5× · PMID 38326704 · DOI 10.5853/jos.2023.01578 -
Early Administration of Edoxaban After Acute Ischemic Stroke in Patients With Non-valvular Atrial Fibrillation: A Pilot Randomized Trial.
Kim JS, Lee KB, Chang DI, Cha JK, et al · · 2023 · cited 2× · PMID 37282378 · DOI 10.5853/jos.2023.00325 -
Early recurrence of ischaemic stroke of cardioembolic cause and delayed anticoagulation: a case report.
Aghetti A, Reiner P. · · 2022 · PMID 35462640 · DOI 10.7573/dic.2021-10-5
Verify or expand the search:
- PubMed search for NCT03433235
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Edoxaban
Trials testing the same drug.
- NCT06285942 — EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation · NA · unknown
- NCT06149533 — Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients · Phase 3 · not yet recruiting
- NCT05804747 — A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fi · completed
- NCT05732506 — Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria · completed
- NCT05540587 — Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis · Phase 2 · recruiting
Other recruiting trials for Acute Ischemic Stroke
Currently open trials in the same condition.
- NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
- NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
- NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
- NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
- NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03433235 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jong Sung Kim
- Last refreshed: 11 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03433235.
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