Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
研究概览
详细说明
Cilostazol is the only medication approved for use in peripheral arterial disease (PAD) patients to reduce claudication symptoms. Contemporary data has demonstrated that Cilostazol improves patency after endovascular interventions in multiple randomized trials and retrospective studies done in Japan in both critical limb ischemia and claudication patients. However, Cilostazol use after peripheral revascularization has been sporadic and there has been no research to estimate patient quality of life with use of Cilostazol after open or endovascular lower extremity revascularization.
This is a prospective investigator initiated single-center open-label, non-placebo controlled pilot study. Eligible patients would be randomized to either the Cilostazol treatment or the non-Cilostazol treatment groups using a closed envelope randomization technique. Twenty patients will be recruited and randomized; Ten to the treatment group and tento the control group.
The primary purpose of this pilot study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required for adequate powered trial of Cilostazol versus usual care without Cilostazol and its effect on Quality of Life.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27106
- Wake Forest Baptist Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- At least 35 years of age
- Atherosclerotic peripheral arterial disease
- Able to provide informed consent
- Lower extremity open or endovascular revascularization.
Exclusion Criteria:
- Known CHF (class III/IV)
- Allergic reaction to phosphodiasterase inhibitors
- Intracranial bleeding within 3 months or active bleeding peptic ulcer disease
- Traumatic vascular injuries requiring revascularization
- Pregnant or breast feeding women or women who plan to get pregnant over the study period
- Planned ipsilateral major amputation within 30 days of index procedure
- Moderate to severe hepatic impairment.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
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100 mg twice daily for 90 days
其他名称：
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无干预：Control
No Cilostazol
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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 |
|---|---|---|
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
大体时间：Baseline and 6 weeks.
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The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up.
Cross-sectional and change scores will be used to project sample size requirements for a full trial.
The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status.
The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression.
Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions.
The EQ5D sum score is a composite sum of the individual dimension scores.
Values of the total score can range from 5 to 25 with higher scores indicating a worse health state.
Separate change scores are estimated at each follow-up time point.
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Baseline and 6 weeks.
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months
大体时间：Baseline and 3 months
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The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up.
Cross-sectional and change scores will be used to project sample size requirements for a full trial.
The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. .
The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression.
Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions.
The EQ5D sum score is a composite sum of the individual dimension scores.
Values of the total score can range from 5 to 25 with higher scores indicating a worse health state.
Separate change scores are estimated at each follow-up time point.
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Baseline and 3 months
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.
大体时间：Baseline and Six Weeks
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The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point. Higher numbers are better. |
Baseline and Six Weeks
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.
大体时间：Baseline and 3 months
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The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point. Higher numbers are better. |
Baseline and 3 months
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Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
大体时间：Baseline and Six Weeks
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The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point. With the EACH-Q higher scores are better. |
Baseline and Six Weeks
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Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months
大体时间：Baseline and 3 months
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The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point. With the EACH-Q higher scores are better. |
Baseline and 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
大体时间：13 days to 259 days
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Graft patency was determined by duplex scan as opened or occluded.
Follow-up duplex testing ranged from 13 days to 259 days.
Number of patency failures (i.e., graft occlusions) are shown below by treatment arm.
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13 days to 259 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Affected by Death
大体时间：90 days
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Number of Participants affected by Death was reported
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90 days
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Patients Who Had Amputations Following Initial Procedure.
大体时间：90 days
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Patients who went on to have amputations following initial procedure
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90 days
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Number of Participants Who Had a Stroke
大体时间：90 days
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Secondary outcome measure - patients who had a stroke during the 90 day follow up period.
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90 days
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Claudication Symptoms and Rest Pain.
大体时间：90 days
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Secondary outcome measures including claudication symptoms and rest pain.
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90 days
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合作者和调查者
调查人员
- 首席研究员：Matthew Edwards, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00030275
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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