A Double-blind, Randomized, Placebo Controlled Pilot Trial to Evaluate the Safety and Efficacy of Vorapaxar in Maturation of Arteriovenous Fistulae for Hemodialysis Access
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Time to AV Fistula Functional Maturation
研究概览
简要总结
The Objectives of this study are:
- To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo.
- To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo.
- To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo.
This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
详细描述
Objectives:
- To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo.
- To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo.
- To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo.
This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
Participation in this study will not affect standard care of patients with AV fistulae receiving hemodialysis. The only additional treatment is administration of the study drug or placebo and additional monitoring, including one additional ultrasound, for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving or planning to receive maintenance hemodialysis
- •Ability to sign informed consent
- •3 mm venous diameter within recipient vein
排除标准
- •History of stroke, transient ischemic attack or intracranial hemorrhage
- •History of or high level of suspicion for, severe arterial insufficiency of the hand
- •Indication or ongoing therapy with other antiplatelet agents, other than aspirin 81 mg daily
- •Indication or ongoing therapy with anticoagulants, including warfarin, low molecular weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.
研究组 & 干预措施
Vorapaxar intervention
This arm will receive the study drug: Vorapaxar sulfate.
The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
干预措施: Vorapaxar sulfate (Drug)
Placebo intervention
This arm will receive the matching placebo.
The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to AV Fistula Functional Maturation
时间窗: up to 238 days
Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks).
次要结局
- Count of All Participants With Bleeding Events(up to 238 days)
- Count of Participants With AV Fistula Use(up to 238 days)
- Count Participants With AV Fistula Patency(150-238 days)
研究者
Ken Mahaffey
Co Investigator
Stanford University