2/2 Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT Trial) –DCC

2/2 肺栓塞：导管定向治疗血栓清除（PE-TRACT 试验）—DCC

• 批准号: 10448731
• 负责人: THADDEUS TARPEY
• 金额: $ 62.28万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10448731
• 关键词: Activities of Daily Living; Acute; Anticoagulant therapy; Anticoagulation; Benefits and Risks; Berry; Biometry; Blinded; Blood Pressure; Budgets; Cardiopulmonary; Catheters; Cessation of life; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Coagulation Process; Consultations; Cost Effectiveness Analysis; Dangerousness; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Set; Databases; Deterioration; Disease; Dose; Economics; Enrollment; Ensure; Event; Excision; Exercise Test; Fibrinolytic Agents; Futility; Gatekeeping; Goals; Health; Heart; Hemorrhage; Infrastructure; Measures; Methodology; Mission; National Heart, Lung, and Blood Institute; New York; Outcome; Outcome Study; Oxygen Consumption; Patients; Phase; Pragmatic clinical trial; Procedures; Process; Protocol Compliance; Public Health; Publications; Pulmonary Embolism; Pulmonary artery structure; Quality Control; Quality of life; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Recurrence; Reporting; Research Design; Resources; Right Ventricular Dysfunction; Right Ventricular Function; Risk; Sample Size; Security; Standardization; Statistical Data Interpretation; Testing; Therapy trial; Thrombolytic Therapy; Thrombus; Time; Walking; Work; Writing; adjudication; adverse event monitoring; clinical center; clinical practice; cost; data de-identification; data integrity; data quality; data repository; data resource; design; disability; effectiveness study; efficacy outcomes; exercise capacity; experience; feasibility trial; follow-up; functional status; improved; incremental cost-effectiveness; innovation; open label; prevent; primary outcome; randomized trial; safety outcomes; screening; thrombolysis; treatment group; trial design; venous thromboembolism

PROJECT SUMMARY The optimal management of patients with submassive pulmonary embolism (PE), who have right heart dysfunction but a normal blood pressure, is uncertain. These patients are at risk for poor short-term outcomes, suffer from reduced functional capacity, and have lower quality of life over the long term. While systemic thrombolysis reduces clinical deterioration from PE, this benefit is offset by substantial increases in major and intracranial bleeding. Catheter-directed therapy (CDT), which dissolves pulmonary artery thrombus with a much lower dose of thrombolytic drug, may be as effective as systemic thrombolytic therapy without substantially increasing bleeding, but it has risks and is costly, and it is not known if it improves cardiopulmonary heath, particularly over the long term. We therefore plan to conduct an open-label, assessor-blinded, randomized trial, the Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT) Study, to compare CDT with No-CDT in up to 500 patients with submassive PE. The trial is adaptive, and could result in enrollment being stopped early for superior efficacy or for futility at an interim analysis. There will be two primary efficacy outcomes: peak oxygen consumption at 3 months (short-term) and New York Heart Association (NYHA) class at 12 months (long-term), analyzed sequentially using a gatekeeping approach; for NYHA class to be compared, peak oxygen consumption must first be shown to be increased by CDT (P<0.05). The primary safety outcome will be major bleeding within 30 days of randomization. The Data Coordinating Center, led by experts with deep experience in adaptive and pragmatic clinical trial design and implementation, will oversee all aspects of study design, implementation, and analysis, and will provide state-of-the-art data collection and quality control infrastructure, reporting to the independent Data and Safety Monitoring Board, and provision of data and resources to the public. The PE-TRACT Study will change clinical practice: if CDT is effective and safe, it will become part of standard therapy for patients with submassive PE; if not, a risky and costly therapy will be avoided. Hence, either study outcome will improve public health and advance the NHLBI’s mission

项目摘要 右心次大面积肺栓塞（PE）患者的最佳治疗 功能障碍但血压正常，是不确定的。这些患者有短期预后不良的风险， 功能能力下降，长期生活质量下降。虽然系统性 溶栓减少了PE的临床恶化，但这一获益被主要和 颅内出血导管导向治疗（CDT），它溶解肺动脉血栓， 低得多剂量的溶栓药物，可能与全身溶栓治疗一样有效， 大幅度增加出血，但它有风险，成本高，而且不知道它是否会改善 心肺健康，特别是长期。 因此，我们计划进行一项开放标签、评估者设盲、随机试验，即肺栓塞： 导管引导治疗血栓清除（PE-TRACT）研究，比较CDT与无CDT患者的 多达500例次大面积PE患者。该试验是适应性的，可能导致招募停止 在中期分析时，因上级疗效或无效而提前。将有两个主要疗效结局：峰值 3个月时的耗氧量（短期）和12个月时的纽约心脏协会（NYHA）分级 （长期），使用把关方法进行顺序分析;对于要比较的NYHA分级，峰值 氧耗量必须首先显示出CDT增加（P<0.05）。主要安全性结局将是 随机化前30天内发生大出血。数据协调中心，由专家领导， 在适应性和实用的临床试验设计和实施方面的经验，将监督研究的各个方面 设计、实施和分析，并将提供最先进的数据收集和质量控制 基础设施，向独立的数据和安全监测委员会报告，以及提供数据和 资源给公众。PE-TRACT研究将改变临床实践：如果CDT有效且安全， 成为亚大块PE患者标准治疗的一部分;如果不是， 避免了因此，任何一项研究结果都将改善公众健康，推进NHLBI的使命