Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Quality of life measures
研究概览
简要总结
To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change in
- time of initial leg pain and time of termination of exercise test by pain, evaluated on the graded stationary bicycle test,
- the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and dynamic contrast enhancement sequences and measures the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization -/+ bypass surgery for moderate to severe claudication or ischemic rest pain.
详细描述
Patients will be randomly assigned to PRU-guided and non-PRU-guided group. In the non-PRU -target group, dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patient followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. In the PRU-target group, dual antiplatelet therapy will be the same protocol as in the non-PRU-target group for patients with PRU <234 seconds. However, for patients in the PRU-target group with PRU ≥234 seconds, rescue medicine will be added to keep PRU<234 seconds.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to any study specific procedures.
- •Ambulatory male or female outpatients with diabetes mellitus aged 18-75 years of age or older at the time of the Screening Visit.
- •Diagnosis of PAD confirmed by history and any one of the following observed in the index (intervention) leg at the Screening Visit:
- •Resting ABI ≤0.90, or
- •In patients with an ABI > 1.40 (non-compressible vessels) a resting GTI <0.70 can be used for inclusions.
- •endovascular +/- bypass surgery for superficial femoral artery and/or popliteal and/or tibial arteries, that is planned to occur within 6 weeks after the screening visit. Patients receiving concomitant iliac artery endovascular procedures may be enrolled as long as their procedure also includes treating the distal SFA, popliteal or tibial arteries. The patient is randomised after revascularization procedure has been confirmed as technically successful.
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •Isolated iliac and/or common femoral arteries lesion.
- •Participation in other clinical study with an investigational product within the last 3 months or any new clinical trial during the course of this study.
- •Gangrene or ischemic ulcer of either lower extremity.
- •PAD of a non-atherosclerotic nature.
- •Chronic oral or parenteral anticoagulant therapy (greater than 7 days)
- •Any health status that would interfere with exercise performance or prevent the patient from completion of MRI examinations.
- •Any major lower limb amputation (minor toe amputations allowed if it does not interfere with ambulation).
- •Myocardial infarction or stroke in the previous 3 months.
- •Any concomitant disease process with a life expectancy of less than 1 year or which is sufficiently severe as to compromise the validity of test performance.
- •Not fully understanding of information pertinent to study conduct or compliance to study procedures.
- •Inability of the patient to comply with study procedures and/or followup (e.g., alcohol or drug abuse).
- •A known bleeding diathesis, hemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing.
- •MRI examination is prohibited due to renal insufficiency or renal failure requiring dialysis. Any condition that can not receiving MRI examination, such as claustrophobia, previous abdominal aortic stent(strong artifact).
- •History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days (if the surgical wound is judged to be associated with an increased risk of bleeding).
- •Hypersensitivity to ticagrelor, aspirin or clopidogrel.
研究组 & 干预措施
PRU-guided
dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. For patients in the PRU-target group with PRU ≥234 seconds, rescue medicine (ticagrelor) will be added to keep PRU<234 seconds.
干预措施: platelet (P2Y12) reaction units (Other)
PRU-guided
dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. For patients in the PRU-target group with PRU ≥234 seconds, rescue medicine (ticagrelor) will be added to keep PRU<234 seconds.
干预措施: ticagrelor (Drug)
PRU-guided
dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period. For patients in the PRU-target group with PRU ≥234 seconds, rescue medicine (ticagrelor) will be added to keep PRU<234 seconds.
干预措施: Comparator (Drug)
non PRU-guided
dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period, regardless the levels of PRU.
干预措施: platelet (P2Y12) reaction units (Other)
non PRU-guided
dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patients with PRU <234 seconds and followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period, regardless the levels of PRU.
干预措施: Comparator (Drug)
结局指标
主要结局
Quality of life measures
时间窗: month 0,12,or Early Termination
To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the quality of life over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
Limb hemodynamics (Ankle Brachial Index or Great Toe Index)
时间窗: month 0,1,6,12,or Early Termination
To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the Limb hemodynamics (Ankle Brachial Index or Great Toe Index) over time (pre-revascularization and at 1, 6, and 12 months post-revascularization) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
leg pain MRI perfusion measures
时间窗: month 0,4,12,or Early Termination
To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the lower leg muscle GOLD perfusion measure over time (pre-revascularization, 4, and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
Peak exercise time
时间窗: month 0,12,or Early Termination
To compare the effects of PRU-guided versus non-PRU-guided treatment on changes in the leg peak exercise time over time (pre-revascularization and 12 months post-revascularization, or early termination ) during 12 months of therapy in patients with Peripheral Artery Disease who have undergone endovascular -/+ bypass surgery revascularization for moderate to severe claudication or ischemic rest pain.
次要结局
- Major lower leg events (above the ankle amputations, revascularization procedures)(month1, 3, 6,9,12,or Early Termination)
- Major bleeding events(month1, 3, 6,9,12,or Early Termination)
- leg pain (claudication) onset time(month 0,12,or Early Termination)
- Major cardiac events (myocardial infarctions, admission due to congestive heart failure and strokes, and death)(month 1, 3, 6,9,12,or Early Termination)
研究者
Chi-Hsiao Yeh
MD PhD
Chang Gung Memorial Hospital