patent foramen ovale
Conditions
Interventions
Trial group:take aspirin
Control group:take aspirin with clopidogrel
Sponsors
Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
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;
Exclusion criteria
Exclusion criteria: (1) Patients who have undergone other cardiac interventions with implanted artificial devices. (2) Surgery requiring discontinuation of antiplatelet drugs is expected to be performed within one year or a stroke has occurred within the last one year. (3) Life expectancy of less than one year. (4) Severe haematological disorders, such as AA, ITP and leukaemia. (5) Intolerance or allergy to aspirin or clopidogrel. (6) Known malignant neoplastic diseases and serious infections. (7) Pregnancy or breastfeeding. (8) known active peptic ulcers. (9) Concomitant need for oral anticoagulants. (10) Patients with stenosis or entrapment of the intracranial arteries. (11) Patients with bleeding disorders of any organ. (12) Concurrent participation in other interventional clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactFengpeng Jia
Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed