David Lee Outpatient Cancer Center, Charleston Area Medical Center, West Virginia University School of Medicine-Charleston Division, Charleston, West Virginia, USA.
Clin Ther. 2010 Apr;32(4):626-36. doi: 10.1016/j.clinthera.2010.04.012.
Desirudin, a bivalent direct thrombin inhibitor (DTI), is approved by the US Food and Drug Administration for the prevention of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery. It became available in the United States in March 2010.
The goal of the present article was to provide an overview of the rationale and design of the PREVENT-HIT study, a randomized, prospective, open-label, active drug-controlled, exploratory trial comparing the clinical and economic utility of desirudin versus argatroban in patients with suspected heparin-induced thrombocytopenia (HIT), with or without thrombosis.
The PREVENT-HIT study was designed to enroll approximately 120 patients from 20 to 25 US centers. All eligible patients were required to be aged >or=18 years. Patients with suspected HIT with or without thrombosis were divided into 2 treatment arms and randomized to receive treatment with desirudin or argatroban in a 1:1 ratio using a block randomization method. Arm A comprised patients who were naive to DTI therapy; arm B included patients whose condition was previously stabilized with intravenous argatroban. Desirudin was administered as a fixed-dose injection (15 or 30 mg SC q12h in patients without or with thrombosis, respectively). Argatroban was administered by continuous intravenous infusion in accordance with approved prescribing information or institutional prescribing guidelines at each study site. The primary efficacy outcome measure included the occurrence of any of the following up to 30 days after study drug discontinuation: new-onset or worsening thrombosis requiring discontinuation of study drug; amputation; or all-cause mortality. Other outcomes that were assessed included platelet recovery, bleeding, and pharmacoeconomic parameters. In addition, adverse events and other safety parameters were evaluated. Study enrollment began in November 2008 and ended in December 2009 due to slow enrollment (N = 16). The study results will be published separately.
The results from the PREVENT-HIT study should enhance understanding of the comparative clinical and economic utility of desirudin and argatroban in patients with HIT with or without thrombosis. ClinicalTrials.gov identifier: NCT00787332.
Desirudin 是一种双价直接凝血酶抑制剂（DTI），于 2010 年 3 月在美国获得批准，用于预防择期髋关节置换手术患者的深静脉血栓形成，这可能导致肺栓塞。
本文旨在概述 PREVENT-HIT 研究的原理和设计，这是一项随机、前瞻性、开放标签、活性药物对照、探索性试验，比较了在疑似肝素诱导血小板减少症（HIT）患者中，使用依诺肝素与 Argatroban 的临床和经济效用，无论是否存在血栓。
PREVENT-HIT 研究计划在 20-25 个美国中心招募约 120 名患者。所有符合条件的患者年龄均需大于等于 18 岁。有或无血栓形成的疑似 HIT 患者被分为 2 个治疗组，使用区组随机化方法以 1:1 的比例随机接受依诺肝素或 Argatroban 治疗。A 臂包括从未接受过 DTI 治疗的患者；B 臂包括病情先前用静脉注射 Argatroban 稳定的患者。依诺肝素以固定剂量注射（无血栓患者每 12 小时皮下注射 15 或 30mg，有血栓患者）。Argatroban 按照批准的处方信息或每个研究地点的机构处方指南连续静脉输注。主要疗效终点包括停药后 30 天内出现以下任何一种情况：新发生或恶化的血栓形成需要停药；截肢；或全因死亡率。评估的其他结果包括血小板恢复、出血和药物经济学参数。此外，还评估了不良事件和其他安全性参数。研究于 2008 年 11 月开始，由于入组缓慢，于 2009 年 12 月结束（N=16）。研究结果将另行公布。
PREVENT-HIT 研究的结果应能增强对依诺肝素和 Argatroban 在有或无血栓形成的 HIT 患者中的比较临床和经济效用的理解。ClinicalTrials.gov 标识符：NCT00787332。
