使用质子泵抑制剂治疗急性静脉血栓栓塞减少胃肠道出血
使用质子泵抑制剂治疗急性静脉血栓栓塞减少胃肠道出血:试点随机研究(RADIANT 研究)
研究概览
详细说明
静脉血栓栓塞 (VTE) 是指身体静脉中形成的血栓,包括手臂或腿部(深静脉血栓 [DVT])、腹部(门静脉血栓)或肺部(肺栓塞 [PE])。 这些血凝块可以用称为抗凝剂的药物来治疗,以减少血液凝结。 抗凝剂的主要并发症是出血,其中大部分来自胃或肠(胃肠道)。 抗凝剂不会引起出血,但可能会使出血更加严重。 罕见情况下,严重的胃肠道 (GI) 出血可能会导致住院甚至死亡。 开始使用抗凝剂后的头几个月出血的可能性最高。
质子泵抑制剂(PPI)是降低胃酸含量的药物。 这项研究中的药物是一种质子泵抑制剂,称为奥美拉唑,在加拿大被批准用于治疗胃溃疡、胃灼热和称为幽门螺杆菌的胃感染。 本研究中奥美拉唑的使用被认为是研究性的。 这意味着加拿大卫生部尚未批准使用奥美拉唑作为预防服用抗凝剂的患者胃肠道出血的治疗方法。 一些研究表明,它们可以减少服用抗凝剂的人的胃肠道出血。
研究人员正在研究一种名为奥美拉唑的质子泵抑制剂治疗是否可以减少服用抗凝剂治疗静脉血栓栓塞的老年人的胃肠道出血。
研究人员计划进行一项大型随机试验,这是测试治疗效果的最佳方法。 为此,本研究的一些参与者将服用奥美拉唑,其他参与者将服用安慰剂(一种看起来像研究奥美拉唑的物质,但不含任何活性或药用成分)。 本研究中的安慰剂不会对出血产生任何影响。 使用安慰剂是为了使研究结果更加可靠。
主要目的 评估全面双盲安慰剂对照随机试验的可行性,以确定与安慰剂相比,奥美拉唑是否可以降低接受抗凝治疗急性 VTE 的老年人上消化道出血的风险。
次要目标:
- 衡量额外的可行性结果
- 衡量信息丰富的结果
- 衡量关键临床结果
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Deborah Siegal, MD
- 电话号码:78804 (613) 737-8899
- 邮箱:dsiegal@toh.ca
参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
纳入标准:
- 注册时年满 65 岁的男性或女性。 由于年龄是出血的一个重要的不可改变的危险因素,因此招募仅限于老年人。 这将确保研究人群包括更有可能从奥美拉唑受益的参与者(与没有风险因素的参与者相比),因为所有参与者都至少有 1 个出血风险因素。
- 过去7天内诊断出的急性VTE,包括任何部位的VTE,例如(但不限于)上肢或下肢DVT、PE、脑静脉血栓、门静脉血栓、其他内静脉血栓。
- 计划使用任何抗凝剂进行 3 个月(90 天)或更长时间的抗凝治疗。
- 患者或代表能够并且愿意遵守同意书中包含的后续检查。
排除标准:
- 目前每日常规使用 PPI(不排除接受 H2 受体拮抗剂的患者),
- 既往上消化道出血,
- 需要双重抗血小板治疗,
- 奥美拉唑的禁忌症(对奥美拉唑或其他取代的苯并咪唑 PPI 过敏,与含有利匹韦林的产品同时使用,由现场调查员自行决定),
- 预期寿命不足3个月。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:奥美拉唑每日剂量 20 mg
随机分配到实验组的参与者在参与研究期间每天口服一粒奥美拉唑 20 毫克片剂。
|
奥美拉唑每天一次,持续 90 天
其他名称:
|
安慰剂比较:安慰剂每日剂量
随机分配到对照组的参与者在参与研究期间每天口服一粒安慰剂片剂。
|
安慰剂每天一次,持续 90 天
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
研究参与中心的可行性
大体时间:24个月
|
每个站点每月招募的平均参与者数量
|
24个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
合格率
大体时间:24个月
|
符合条件的筛查患者比例
|
24个月
|
同意率
大体时间:24个月
|
同意的符合条件的患者比例
|
24个月
|
保留率
大体时间:27个月
|
完成所有研究程序的参与者比例
|
27个月
|
依从率
大体时间:27个月
|
通过药丸计数或随访结束时评估患者日记来衡量对研究药物的依从性
|
27个月
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
风险因素
大体时间:24个月
|
基线时具有以下出血危险因素的参与者比例: 肾功能下降(定义为估计肾小球滤过率 [eGFR] <60 mL/min/1.73
m2)、活动性癌症、同时抗血小板和/或 NSAID 治疗、慢性肝病、慢性贫血。
|
24个月
|
患者已经开了质子泵抑制剂
大体时间:24个月
|
已经接受规定的质子泵抑制剂治疗的筛选患者的比例
|
24个月
|
参与减少的原因
大体时间:24个月
|
患者无需提供拒绝参加的理由。
然而,对于那些愿意分享的患者,将审查拒绝参与的原因
|
24个月
|
新的 PPI 处方
大体时间:27个月
|
研究期间服用质子泵抑制剂新处方的参与者比例
|
27个月
|
复发性静脉血栓栓塞
大体时间:27个月
|
研究期间复发静脉血栓栓塞的患者比例
|
27个月
|
死亡
大体时间:27个月
|
研究期间死于消化道出血的患者比例以及全因死亡率
|
27个月
|
严重不良事件
大体时间:27个月
|
研究期间发生严重不良事件的患者比例
|
27个月
|
与健康相关的生活质量的变化
大体时间:27个月
|
与基线相比,90 天时通过 EuroQol EQ-5D-5L 生活质量问卷测量的健康相关生活质量的变化。
该调查问卷包括患者对其健康的看法,包括行动能力、自我护理、日常活动、疼痛或不适以及焦虑或抑郁。
最低分数为 5 分,最高分数为 25 分。
分数越低代表生活质量越差。
问卷还包括一个可见的模拟量表,要求患者描绘一条编号从 0 到 100 的垂直线。线顶部的 100 表示患者可以想象的最佳健康状况,线底部的 0 表示患者的最佳健康状况。病人能想象到的最糟糕的健康状况。
患者在填写问卷时被要求提供最能代表其健康状况的数字。
|
27个月
|
功能状态变化
大体时间:27个月
|
与基线相比,90 天时通过老年人全球活动标准评估 (SAGE) 量表测量的功能状态变化。
SAGE 调查问卷衡量患者在社区和家中所做的事情。
要求患者指出过去一个月中每个问题的难度程度,并回答无困难、轻度、中度或重度困难。
轻度 = 最小/偶尔的困难,不影响执行活动或任务的能力;中等=一些/常规难度确实影响执行任务的能力,尽管他们仍然能够执行任务;严重 = 执行任务极其/持续困难,或者任务由于困难而未完成和/或由其他人完成。
|
27个月
|
临床相关上消化道出血事件
大体时间:27个月
|
经判定的临床相关上消化道出血(主要上消化道出血加上临床相关非主要 [CRNM] 上消化道出血,改编自国际血栓与止血学会 (ISTH) 关于主要出血和 CRNM 出血的标准)。
|
27个月
|
内镜确诊的上消化道出血率
大体时间:27个月
|
随机分组后 30、60 和 90 天经内窥镜证实出现上消化道出血的患者比例
|
27个月
|
下消化道出血率
大体时间:27个月
|
随机分组后 30、60 和 90 天出现下消化道出血的患者比例
|
27个月
|
所有主要消化道出血
大体时间:27个月
|
随机分组后 30 天、60 天和 90 天经裁定确认发生严重胃肠道出血的患者比例
|
27个月
|
所有临床相关的非严重胃肠道出血
大体时间:27个月
|
在第 30 天、60 天、90 天时经裁定确认有临床相关非严重胃肠道出血的患者比例
|
27个月
|
所有大出血
大体时间:27个月
|
随机分组后 30、60、90 天经判定确认发生大出血(包括大胃肠道出血)的患者比例
|
27个月
|
所有临床相关的非大出血
大体时间:27个月
|
随机分组后 30、60 和 90 天确认发生临床相关非大出血(包括 CRNM 胃肠道出血)的患者比例
|
27个月
|
消化道出血住院
大体时间:27个月
|
随机分组后 30、60 和 90 天因胃肠道出血住院的患者比例
|
27个月
|
合作者和调查者
调查人员
- 首席研究员:Deborah Siegal, MD、Ottawa Hospital Research Institute
出版物和有用的链接
一般刊物
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研究记录日期
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研究完成 (估计的)
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首次发布 (实际的)
研究记录更新
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