Last reviewed · How we verify
NCT03749057: ERSAF
Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation
Phase 4 trial testing Rivaroxaban in Cerebral Infarction in 400 participants. Completed in 30 March 2025.
30 March 2025
Quick facts
| Lead sponsor | General Hospital of Shenyang Military Region |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 20 November 2018 |
| Primary completion | 30 March 2025 |
| Estimated completion | 30 March 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Rivaroxaban (rivaroxaban) — full drug profile →
Conditions studied
- Cerebral Infarction — all drugs for Cerebral Infarction →
- TIA — all drugs for TIA →
Sponsor
General Hospital of Shenyang Military Region
Who can join
18 and older, any sex, with Cerebral Infarction or TIA. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and national guidelines for the management of anticoagulation recommend that most of AF patients with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days of symptom onset, while European guidelines recommend that the timing of the initiation of non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction or TIA is association with stroke severity in light of the "1-3-6-12" principle. However, there are still many problems about the use of NOACs in ischemic stroke with AF. for example, it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score. Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot. ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. Recent study indicates that early administration with rivaroxaban for AF patients within 14 days of onset does not significantly increase hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in China. Therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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 NCT03749057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rivaroxaban
Trials testing the same drug.
- NCT06953726 — Comparing the Safety and Efficacy of Apixaban and Rivaroxaban · Phase 4 · not yet recruiting
- NCT07468448 — Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe · Phase 3 · not yet recruiting
- NCT07318610 — Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease · Phase 3 · not yet recruiting
- NCT07312851 — A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Parti · Phase 1 · recruiting
- NCT06961630 — Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction · EARLY_PHASE1 · recruiting
Other recruiting trials for Cerebral Infarction
Currently open trials in the same condition.
- NCT06757764 — The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis · Phase 4 · recruiting
- NCT07081568 — Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction · NA · recruiting
- NCT07018167 — Impact of Door-to-Needle Time on Stroke Outcomes at Gonesse Hospital · active not recruiting
- NCT04696523 — Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage · Phase 2 · recruiting
- NCT06712004 — A Dose-Response Controlled Trial of Bevifibatide for Acute Ischemic Stroke · Phase 2 · recruiting
Other General Hospital of Shenyang Military Region trials
Trials by the same sponsor.
- NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
- NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
- NCT07462546 — Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS) · NA · recruiting
- NCT07294885 — Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease · NA · recruiting
- NCT07412249 — Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis · NA · 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 NCT03749057 (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 General Hospital of Shenyang Military Region
- Last refreshed: 21 August 2025
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/NCT03749057.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing