Dabigatran for Mitral Stenosis Atrial Fibrillation

Launched by THE UNIVERSITY OF HONG KONG · Aug 2, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called dabigatran for patients who have atrial fibrillation (AF) and moderate to severe mitral stenosis (MS). Atrial fibrillation is a condition where the heart beats irregularly, which can increase the risk of strokes. While newer medications called non-vitamin K oral anticoagulants (NOACs) are often preferred for stroke prevention in many AF patients, there is still limited information about their safety and effectiveness specifically for patients with mitral stenosis. This trial aims to compare NOACs like dabigatran with the traditional blood thinner warfarin in this particular group of patients.

To participate in this study, individuals need to be at least 18 years old and must have documented atrial fibrillation and moderate to severe mitral stenosis. They should also be able to give written consent to join the trial. However, certain people, such as those with specific heart conditions, recent surgeries, or serious bleeding issues, may not be eligible. Participants can expect to be closely monitored throughout the trial, and their health will be regularly assessed to ensure safety. This study is currently recruiting participants, and it offers a chance to contribute to important research that could help improve treatment options for patients with these heart conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with atrial fibrillation documented with standard 12-lead ECG documented atrial fibrillation on the day of screening or randomization
• • Patients with age ≥ 18 years
• • Patients with moderate or severe mitral stenosis, i.e. mitral valvular area (MVA) ≤ 2.5cm2
• • Patients should be able to provide a written informed consent
• • Patients should have all 4 inclusion-criteria fulfilled to be qualified for the study
• Exclusion Criteria:
• • Patients with mechanical prosthetic valve, or with active endocarditis
• • Patients with planned valvular intervention within 1 year
• • Patients with left atrial appendage occlusive device
• • Patients with planned AF ablation
• • Unexplained anemia (haemoglobin level \< 10g/dL) or thrombocytopenia (platelet count \< 100x10\*9/L)
• • Need for anticoagulant therapy of disorders other than atrial fibrillation
• • Patients receiving antiplatelet therapy for disorders other than atrial fibrillation
• • Uncontrolled hypertension (systolic blood pressure \> 180mmHg and/or diastolic blood pressure \> 100mmHg)
• • Estimated creatinine clearance ≤ 30mL/min
• • Liver dysfunction of Child Pugh stage B or C
• • Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
• • Patients considered unreliable by the investigator or have a life expectancy less than 1 year because of concomitant disease, or has any condition, which in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse)