Data Coordinating Centre for ATTRACT Trial

ATTRACT 试验数据协调中心

• 批准号: 7827977
• 负责人: Clive Kearon
• 金额: $ 47.05万
• 依托单位: MCMASTER UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-29 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7827977
• 关键词: Acute; Aftercare; Anatomy; Anticoagulant therapy; Arts; Blinded; Catheters; Cessation of life; Clinical; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Communities; Data; Data Collection; Data Coordinating Center; Data Set; Databases; Deep Vein Thrombosis; Diagnosis; Disease; Economics; Elements; Enrollment; Event; Excision; Frequencies; Generic Drugs; Goals; Health Care Costs; Hematological Disease; Hemorrhage; Iliac Vein; Image; Impairment; Leg Ulcer; Life Style; Low Prevalence; Measurement; Medical; Methods; Minor; Mission; Morbidity - disease rate; Negative Finding; Outcome; Outcome Measure; Outcome Study; Parents; Patients; Phase; Phlebography; Postphlebitic Syndrome; Prevention; Prevention strategy; Procedures; Process; Protocols documentation; Public Health; Publications; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Reflux; Reliance; Reporting; Research; Residual state; Resolution; Safety; Sample Size; Screening procedure; Secure; Severities; Symptoms; Thrombus; Translating; Treatment outcome; Veins; Venous; Venous Thrombosis; Work; Writing; adjudication; clinical practice; clinically significant; cost effectiveness; design; disability; follow-up; improved; innovation; open label; prevent; randomized trial; risk benefit ratio; thrombolysis

Description (provided by applicant): Post-Thrombotic Syndrome (PTS) develops frequently (25-50%) in patients with proximal deep vein thrombosis (DVT) despite the use of standard anticoagulant therapy. PTS leads to lifestyle-limiting symptoms, work disability, leg ulcers, quality of life (QOL) impairment, and major healthcare costs. Preliminary studies indicate that image-guided Endovascular Thrombus Removal procedures can rapidly restore deep venous patency and thereby prevent PTS in acute proximal DVT patients. However, these studies are limited by reliance upon surrogate anatomic outcome measures of limited clinical significance, non-randomized design, single-center design, and small sample size. For this reason, there currently exists major controversy within the medical community as to whether or not Endovascular Thrombus Removal should be routinely used in the first-line treatment of acute proximal DVT. The long-term goal of the proposed project is to determine whether Endovascular Thrombus Removal should be translated into widespread, first-line use in patients with acute DVT. In the proposed study, we will conduct a Phase III, multicenter, open label, assessor-blinded, randomized controlled trial entitled "Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)" to determine whether the use of Pharmacomechanical Catheter-Directed Thrombolysis (PCDT), a state-of-the-art Endovascular Thrombus Removal method, results in a) a lower prevalence of PTS and b) superior quality of life (QOL), two clinically important treatment outcomes, in symptomatic, first episode, acute proximal DVT patients. The proposed research is both innovative and significant. The study will be the first multicenter randomized trial to evaluate a state-of-the-art image-guided endovascular strategy for the prevention of PTS. If the study establishes a favorable risk-benefit ratio for PCDT, this finding will fundamentally change clinical practice and enable prevention of PTS in thousands of DVT patients. If PCDT does not prevent PTS or if its risk-benefit ratio proves to be unfavorable, this finding will reduce or eliminate the routine use of a costly and potentially risky therapy. Hence, either outcome of the proposed study will greatly improve clinical practice and decrease morbidity in patients with acute DVT, a common blood disorder. Therefore, the study will clearly improve public health and advance the NHLBI's mission. Project Narrative: The ATTRACT Trial will determine whether Pharmacomechanical Catheter-Directed Thrombolysis can prevent the Post-Thrombotic Syndrome (PTS) in patients with Deep Vein Thrombosis (DVT). If the Trial is positive, this finding will conclusively validate the "Open Vein Hypothesis" and thereby a) immediately enable prevention of PTS, a common, morbid, and expensive condition, in thousands of DVT patients each year; and b) catalyze a fundamental shift towards a new treatment paradigm in which early venous thrombus removal is considered an essential element of initial DVT therapy. If the Trial is negative, this finding will eliminate the routine use of a costly and potentially dangerous therapy. Hence, either study outcome will decrease morbidity from DVT, improve public health, and advance the NHLBI's mission.

描述（由申请方提供）：尽管使用了标准抗凝治疗，但血栓后综合征（PTS）在近端深静脉血栓形成（DVT）患者中频繁发生（25-50%）。PTS导致生活方式限制症状、工作残疾、腿部溃疡、生活质量（QOL）受损和重大医疗费用。初步研究表明，图像引导血管内血栓清除术可快速恢复深静脉通畅，从而预防急性近端DVT患者的PTS。然而，这些研究受限于依赖于临床意义有限的替代解剖结局指标、非随机设计、单中心设计和小样本量。因此，目前医学界对于是否应将血管内血栓清除术常规用于急性近端DVT的一线治疗存在重大争议。该项目的长期目标是确定血管内血栓清除术是否应广泛应用于急性DVT患者的一线治疗。在拟定的研究中，我们将进行一项III期、多中心、开放标签、评估者设盲、随机对照试验，标题为“急性静脉血栓形成：使用辅助导管导向溶栓（ATTRACT）进行血栓清除，以确定使用药物机械导管导向溶栓（PCDT）（一种最先进的血管内血栓清除方法），导致a）PTS患病率较低和B）上级生活质量（QOL），这是有症状的首次发作急性近端DVT患者的两种临床重要治疗结局。本研究具有创新性和重要意义。该研究将是第一项多中心随机试验，旨在评价预防PTS的最先进的图像引导血管内策略。如果这项研究为PCDT建立了有利的风险-受益比，这一发现将从根本上改变临床实践，并使成千上万的DVT患者能够预防PTS。如果PCDT不能预防PTS，或者其风险效益比被证明是不利的，这一发现将减少或消除昂贵和潜在风险的治疗的常规使用。因此，所提出的研究的任何一种结果都将大大改善临床实践，降低急性DVT（一种常见的血液疾病）患者的发病率。因此，这项研究将明显改善公众健康，推进NHLBI的使命。 项目叙述：ATTRACT试验将确定药物力学导管导向溶栓是否可以预防深静脉血栓形成（DVT）患者的血栓后综合征（PTS）。如果试验是积极的，这一发现将最终验证“开放静脉假说”，从而a）立即能够预防PTS，一种常见的，病态的，和昂贵的条件，每年在数千名DVT患者;和B）催化一个根本的转变，向一个新的治疗模式，其中早期静脉血栓清除被认为是一个基本要素的初始DVT治疗。如果试验结果为阴性，则这一发现将消除常规使用昂贵且具有潜在危险的治疗。因此，任何一项研究结果都将降低DVT的发病率，改善公众健康，并推进NHLBI的使命。