Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- This study will capture the following hemostatic endpoints: • Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex) • Platelet activation (e.g. P-selectin, CD40 ligand) • Von Willebrand Factor Antigen (VWF Ag) • Beta-thrombglobulin (beta-TG) • Plasminogen activator inhibitor-1 (PAI-1) • D-dimer • Thrombin Generation Test • Anti Xa activity
研究概览
简要总结
The goal of the study is to evaluate hemostasis, such as coagulation activation, thrombin generation and platelet reactivity following catheter-based closure of patent foramen ovale or atrial septal defect. Differences between post-procedural regimen (i.e. DAPT and rivaroxaban) will be assessed in the current pilot study.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
This study will capture the following hemostatic endpoints: • Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex) • Platelet activation (e.g. P-selectin, CD40 ligand) • Von Willebrand Factor Antigen (VWF Ag) • Beta-thrombglobulin (beta-TG) • Plasminogen activator inhibitor-1 (PAI-1) • D-dimer • Thrombin Generation Test • Anti Xa activity
This study will capture the following hemostatic endpoints: • Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex) • Platelet activation (e.g. P-selectin, CD40 ligand) • Von Willebrand Factor Antigen (VWF Ag) • Beta-thrombglobulin (beta-TG) • Plasminogen activator inhibitor-1 (PAI-1) • D-dimer • Thrombin Generation Test • Anti Xa activity
次要结局
未报告次要终点
研究者
Errol Aarnink
Scientific
Sint Antonius Ziekenhuis Stichting