Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

Launched by SUNG-HWAN KIM · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called edoxaban compared to warfarin in patients who have both atrial fibrillation (an irregular heartbeat) and mitral stenosis (a narrowing of the heart's mitral valve). The main goal is to see how well these medications can prevent serious issues like strokes and blood clots while also monitoring for any significant bleeding risks.

To be eligible for the trial, participants need to be between 18 and 80 years old and have been diagnosed with atrial fibrillation and moderate to severe mitral stenosis. The trial is open to all genders and is currently recruiting participants. Those who join the study will be randomly assigned to receive either edoxaban or warfarin, and they will be closely monitored throughout the process. It's important to note that certain health conditions or medications may prevent someone from participating, so potential candidates will be carefully evaluated before enrollment. Overall, this study aims to find out which medication is safer and more effective for these patients.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 18 \< Age \< 80
• • AF diagnosed by ECG at any time prior to enrollment
• • Moderate or severe mitral valve stenosis diagnosed by echocardiography at any time prior to enrollment
• • Exclusion criteria
• • Refusal to consent
• • Transient AF due to reversible cause (Postoperative, ongoing systemic inflammation, thyrotoxicosis)
• • Patients undergoing mechanical valve replacement
• • Coagulopathy
• • Hepatic impairment with significant bleeding risk
• • High bleeding risk due to following disease or condition diagnosed within 1 month prior to randomization
• • GI ulcer or bleeding, Esophageal or gastric varix, Malignancy, Brain or cord injury, Surgery for brain, spinal cord, opthalmic, Intracranial hemorrhage, Arteriovenous malformation, Vascular aneurysms, Brain or spinal vascular disorder
• • Stroke, Systemic arterial thromboembolism, Acute myocardial infarction diagnosed within 14 days prior to randomization
• • End stage kidney disease (CrCL \< 15mL/min) or Dialysis
• • Severe hypertension
• • Alcohol abuse or other psychiatric disease
• • Epidural puncture or anesthesia
• • Pulmonary thromboembolism with hemodynamical instability requiring thrombolysis or thrombectomy
• • Pregnant or lactating women
• • Allergy to edoxaban or warfarin
• • Ongoing need for other anticoagulant or clarithromycin, rifampin)
• • Participants for other trials within 1 month prior to enrollment
• • Other patients to be inappropriate to participate in the trial determined by the investigator