Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS).
研究概览
简要总结
This is a phase IV, multi-center, double-blind, randomized, placebo- controlled study evaluating the effect of alirocumab on SVG atherosclerotic disease burden, as assessed by IVUS at baseline and following 78 weeks of treatment in subjects with at least one intermediate SVG lesion receiving optimal statin therapy. Subjects will be randomized 1:1 into 2 treatment groups: alirocumab 150 mg subcutaneously every 2 weeks or placebo subcutaneously every 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age 18 years or greater.
- •Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- •Undergoing clinically-indicated coronary and SVG angiography.
- •Have at least one target saphenous vein graft with an intermediate SVG lesion (defined as a lesion with 30-60% angiographic diameter stenosis) amenable to examination with IVUS. The SVG should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for angiography.
- •Receiving optimal statin therapy defined as use of a high intensity statin (atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily), any statin therapy with achieved LDL-C level <70mg/dL, or maximally-tolerated statin dose for patients who are statin intolerant statin.
排除标准
- •Positive pregnancy test or breast-feeding.
- •Coexisting conditions that limit life expectancy to less than 18 months or that could affect a patient's compliance with the protocol.
- •Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m
- •Severe peripheral arterial disease limiting vascular access.
- •History of allergic reaction to iodine-based contrast agents that cannot be premedicated.
- •Known hypersensitivity to alirocumab.
- •Any prior use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor therapy.
研究组 & 干预措施
Alirocumab 150 MG/ML subcutaneous injection
Alirocumab 150 mg subcutaneously every 2 weeks
干预措施: Alirocumab 150 MG/ML subcutaneous injection (Drug)
Matching Placebo subcutaneous injection
Matching placebo subcutaneously every 2 weeks
干预措施: Matching Placebo subcutaneous injection (Drug)
结局指标
主要结局
Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS).
时间窗: 78 weeks
To evaluate the effect of alirocumab on the change in burden of saphenous vein graft (SVG) atherosclerosis as measured by percent atheroma volume (PAV) in patients with intermediate SVG lesions who are undergoing clinically-indicated coronary angiography and are receiving optimal statin therapy.
次要结局
- Angiographic failure of target SVG lesion from baseline to 78 weeks.(78 weeks)
- Nominal change in TAV and normalized TAV of an intermediate SVG lesion from baseline to 78 weeks(78 weeks)
- Incidence of target SVG failure and major adverse cardiac events.(Randomization to 80 weeks)