Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Emb… (NCT03284827) | Clinical Trial Compass
CompletedPhase 4
Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
Hong Kong, South Korea, Taiwan235 participantsStarted 2018-03-15
Plain-language summary
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic resonance (MR) imaging) in patients without an absolute indication for chronic oral anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients 19 years of age or older with successful TAVR procedure
✓. correct positioning of a single prosthetic heart valve into the proper anatomical location AND
✓. Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch\* and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, no moderate or severe prosthetic valve regurgitation AND
✓. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure.
✓. Patients who voluntarily participated in the written agreement
Exclusion criteria
✕. Any atrial fibrillation with an indication for chronic OAC.
✕. An ongoing indication for OAC or any other indication for continued treatment with any OAC
✕. Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12 months)
✕. Planned coronary or vascular intervention or major surgery
✕. Clinically significant bleeding patients
✕. The risk of bleeding increased due to the following reasons at the time of TAVR procedure, i. history of gastrointestinal ulcers within 1 month ii. Malignant tumor with high risk of bleeding iii. Brain or spinal cord injury within 1 month iv. History of intracranial or intracerebral hemorrhage within 12 months v. Esophageal varices vi. Arteriovenous malformation vii. Vascular aneurysms viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities ix. Active bleeding x. Hemoglobin level \<7.0 g/dL or platelet count ≤ 50,000 / mm3 xi. History of major surgery within 1 month