Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves (NOTION-4)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- HALT after 1 year
研究概览
简要总结
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.
详细描述
The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
- •Residing in Denmark
- •Provided written informed consent
排除标准
- •Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
- •Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding
- •Patients with severe renal insufficiency (eGFR <30 mL/min/1.73 m2)
- •Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI
- •Iodine contrast allergy or other condition that prohibits CT imaging
- •Age <18 years
- •Women of childbearing potential, pregnant or nursing
研究组 & 干预措施
Sinus rhythm - DOAC treatment
Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin.
Duration: 3 months, followed by an anti-platelet hereafter.
干预措施: Rivaroxaban (Drug)
Sinus rhythm - DOAC treatment
Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin.
Duration: 3 months, followed by an anti-platelet hereafter.
干预措施: Edoxaban (Drug)
Sinus rhythm - DOAC treatment
Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin.
Duration: 3 months, followed by an anti-platelet hereafter.
干预措施: Dabigatran (Drug)
Sinus rhythm - DOAC treatment
Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin.
Duration: 3 months, followed by an anti-platelet hereafter.
干预措施: Apixaban (Drug)
Sinus rhythm - DOAC treatment
Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin.
Duration: 3 months, followed by an anti-platelet hereafter.
干预措施: Warfarin (Drug)
Sinus rhythm - Anti-platelet treatment
Can be either of the following anti-platelet components: acetylsalicylic acid or clopidogrel.
Duration: Lifelong
干预措施: Acetylsalicylic acid (Drug)
Sinus rhythm - Anti-platelet treatment
Can be either of the following anti-platelet components: acetylsalicylic acid or clopidogrel.
Duration: Lifelong
干预措施: Clopidogrel (Drug)
结局指标
主要结局
HALT after 1 year
时间窗: At 1 year after TAVI
The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.
次要结局
- Combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding(At 1 year and 5 years after TAVI)
- Incidence of patients with HALT during follow up(At 3 months, 1 year and 5 years after TAVI)
- HALT on leaflets(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with ischemic stroke(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with stroke(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with all-cause death(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with cardiovascular mortality(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with bleeding(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with re-intervention(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with aortic bioprosthetic dysfunction(At 3 months, 1 year and 5 years after TAVI)
- Number of participants with bioprosthetic valve failure(At 3 months, 1 year and 5 years after TAVI)
- NYHA classification(At 3 months, 1 year and 5 years after TAVI)
- Quality of life scores with 5-level EQ-5D version (EQ5D-5L)(At 3 months, 1 year and 5 years after TAVI)
- Quality of life scores with EQ Visual Analogue Scale (EQ VAS)(At 3 months, 1 year and 5 years after TAVI)
研究者
Ole De Backer
Associate professor
Rigshospitalet, Denmark