Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect - POPular CLOSE

St. Antonius Hospital0 个研究点目标入组 52 人开始时间: 2022年3月31日最近更新: 2022年5月2日

试验速览

暂无简介。

•- The subject is aged 18 years or older
•- The subject is scheduled for percutaneous closure of a PFO or ASD as indicated by the treating physician
•- The subject is able to understand and is willing to provide written informed consent to participate in the trial
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 47
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Unable or unwilling to return for required follow-up visits
•- High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical
•- Mechanical heart valves or valvular disease requiring surgery or interventional procedure
•- Ongoing major bleeding or complicated or recent (<72 hours) major surgery
•- Severe thrombocytopenia (<50.000/ml)
•- Mitral valve regurgitation grade 3 or more
•- Aortic valve stenosis (AVA<1.0cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more
•- Left ventricular ejection fraction <30%
•- Life expectancy of less than 1 year
•- Any indication for long-term oral anticoagulation other than presence/closure of a PFO/ASD (such as atrial fibrillation)
•- Any indication for long-term (dual) antiplatelet therapy other than presence/closure of a PFO/ASD (such as recent coronary stenting)
•- Contraindication for the use of rivaroxaban or DAPT (e.g. history of intracranial bleeding) in the investigator's opinion
•- Pregnant or planning to become pregnant during the time of the study
•- Estimated glomerular filtration rate <50 ml/min/1.73m2
•- Use of medication that significantly interacts with rivaroxaban; medication that inhibits cytochrome P450 3A4 or P-glycoprotein (such as ketoconazole, human immunodeficiency virus (HIV) protease inhibitors, clarithromycin, erythromycin and fluconazole) or induces cytochrome P450 3A4 (such as rifampicin and several anti-epileptic drugs).

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