2023-508208-40-00招募中3 期
Short versus long antiplatelet therapy after TAVI
Centre Hospitalier Universitaire De Caen Normandie16 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2024年3月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 16
- 主要终点
- Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI
研究概览
简要总结
Non-inferiority of the experimental arm (3 months therapy with 75 to 100 mg oral aspirin) compared to standard arm (12 months therapy with 75 to 100 mg oral aspirin) on a composite clinical event at 12 months follow-up
研究设计
- 分配方式
- Randomized
- 主要目的
- Inclusion
- 盲法
- Single (Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 o Successful access, delivery of the device, and retrieval of the delivery system o Correct positioning of a single prosthetic heart valve into the proper anatomical location o Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication
- •Written informed consent
- •Social security affiliated
- •French speaking
- •Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female
排除标准
- •Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI
- •Women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-
- •Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
- •TAVI for other indications than aortic stenosis (pure aortic regurgitation)
- •Valve in valve TAVI
- •Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
- •Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization
- •Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
- •Any contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia < 50 000, major haemostasis disorder…)
- •Adult with protective measures (tutorship, curatorship)
结局指标
主要结局
Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI
Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI
次要结局
- • Any non-procedure-related bleeding defined by the VARC classification 1 to 4
- • Major or disabling or life threatening bleeding defined by VARC classification 2 or 3
- • Major cardiovascular events defined by the composite of all cause death, myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury
- • Type 1 VARC classification bleeding
- • Type 2 VARC classification bleeding
- • Type 3 VARC classification bleeding
- • Fatal bleeding defined by Type 4 VARC classification
- • Death
- • Cardiovascular death
- • Type 1 myocardial infarction based on the universal definition
- • Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury
- • Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury
- • Transient cerebral ischemic attack defined by NeuroARC type 3a
- • Any hospitalization
- • Cardiovascular hospitalization
- • VARC-defined prosthetic valve thrombosis
- • VARC-3 defined Cardiovascular hospitalization
- • Death at 2 years (national mortality database)
研究者
National coordinator
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (16)
Loading locations...
相似试验
招募中
3 期
Antiplatelet therapy after successful percutaneous coronary intervention for chronically occluded coronary artery: A prospective, multicentre, randomized study comparing two durations of dual antiplatelet therapy2023-508148-23-01Assistance Publique Hopitaux De Marseille660
暂停
4 期
The SORT OUT XII DAPT Duration Trial2024-515236-69-00Odense University Hospital3,150
招募中
3 期
Short Versus Long Antiplatelet Therapy After TAVITranscatheter Aortic Valve ReplacementNCT06518317University Hospital, Caen1,400
进行中（未招募）
1 期
Short versus long antiplatelet therapy after TAVIAll adult patients with successful transfemoral trans-aortic valve implantation (TAVI ) for symptomatic aortic stenosis (AS) with no other indication for long term antiplatelet or anticoagulant therapyMedDRA version: 20.1Level: LLTClassification code: 10041974Term: Stenosis aortic valve Class: 10007541CTIS2023-508208-40-00Centre Hospitalier Universitaire De Caen Normandie1,400
已完成
4 期
A study designed to evaluate a modified Anti-Platelet Therapy (drugs that preventblood platelets from clotting) after implantation of a Firehawk drug-eluting stent (metallic tube, which is covered with a drug and inserted into stenosed blood vessels of the heart in order to keep them open) in patients who have experienced a heart attack and were treated with complete revascularisation (the lesion related to the heart attack and all other significant lesions were treated)Acute Myocardial Infarction2024-519854-35-00SORIN CRM SAS (Microport CRM)695