Skip to content

A Precision Medicine-Based Study on the Efficacy and Safety of Novel Oral Anticoagulant Dosage in Patients with Acute Ischemic Stroke and Non-Valvular Atrial Fibrillation

A Precision Medicine-Based Study on the Efficacy and Safety of Novel Oral Anticoagulant Dosage in Patients with Acute Ischemic Stroke and Non-Valvular Atrial Fibrillation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106044
Enrollment
Unknown
Registered
2025-07-16
Start date
2023-08-15
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke complicated with nonvalvular atrial fibrillation

Interventions

Observation group:Rivaroxaban 20mg/15mg qd po, OR dabigatran etexilate 150mg bid po
Control group:Rivaroxaban 10mg qd po, OR dabigatran etexilate 110mg bid po

Sponsors

Nanjing drum tower hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the guidelines, and be diagnosed with acute ischemic stroke by head CT or MRI; 2. The electrocardiogram or ambulatory electrocardiogram meets the diagnostic criteria for atrial fibrillation, and there is no rheumatic severe mitral stenosis, prosthetic valve replacement or valve repair surgery; 3. Patients taking rivaroxaban or dabigatran etexilate; 4. The patient can sign the informed consent form; 5. Complete clinical case data and related examination results.

Exclusion criteria

Exclusion criteria: 1. Bleeding disorder or thrombocytopenia (<50×10^9/L) before the use of anticoagulant drugs after the onset of this disease; 2. History of gastrointestinal or urinary tract bleeding in the past 1 month; 3. History of cerebral hemorrhage in the past 3 months; 4. Creatinine clearance < 15 mL/min; 5. Recent combination of drugs that may affect the blood concentration of NOACs, such as antifungal drugs including ketoconazole, itraconazole and fluconazole; 6. Those who switch to other anticoagulant drugs during medication; 7. Patients who are allergic to rivaroxaban and dabigatran etexilate; 8. Patients with incomplete data.

Design outcomes

Primary

MeasureTime frame
mRS score;Clinically relevant major bleeding events;Recurrence ischemic stroke;

Secondary

MeasureTime frame
Myocardial infarction;Systemic embolism;Clinically relevant non-major bleeding events;Non-bleeding adverse events;

Countries

China

Contacts

Public ContactJiang Chenxiao

Nanjing drum tower hospital

sharejcx@163.com+86 177 6173 2923

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026