A randomized controlled study of aspirin combined with and without clopidogrel in postoperative antiplatelet therapy after patent foramen ovale closure

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Trial group:take aspirin;Control group:take aspirin with clopidogrel; CONDITION: patent foramen ovale PRIMARY OUTCOME: Thrombosis rate on the surface of the blocker at 1 and 6 months postoperatively;Incidence of ischaemic stroke at 1 and 6 months postoperatively;Incidence of myocardial infarction at 1 and 6 months postoperatively;Incidence of bleeding events at BARC 2, 3, and 5 at 1 and 6 months postoperatively;Incidence of all‐cause mortality at 1 and 6 months post‐operatively; SECONDARY OUTCOME: Incidence of atrial fibrillation at 1 and 36months postoperatively;Incidence of palpitations at 1 and 6 months postoperatively;Incidence of heart failure at 1 and 6 months postoperatively;HIT‐6 scores at 1 and 6 months post‐operatively;Haemoglobin values at 1 and 6 months postoperatively;Platelet values at 1 and 6 months postoperatively;Prothrombin time and activated partial thromboplastin time at 1 and 6 months postoperatively;Incidence of BARC1 bleeding events at 1 and 6 months postoperatively;Residual shunt at 6 months postoperatively; INCLUSION CRITERIA: 1. All patients 15‐75 years of age with successful transcatheter PFO occlusion using the Amplatzer occluder; 2. No previous history of PCI surgery and no history of persistent atrial fibrillation; 3. No aspirin or other anti‐platelet aggregating drugs have been used within 1 month prior to admission;
Epistemonikos ID: 8d8eec8d723997a5386456d56a38bbf4e5943dfb
First added on: Feb 20, 2024