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Original PI left institution
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Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required to adequately power a trial of Cilostazol versus usual care without Cilostazol and its effect on quality of life.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol | Active Comparator | Administer Cilostazol100 mg twice daily for 90 days. |
|
| Control | No Intervention | No Cilostazol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | 100 mg twice daily for 90 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | 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. | Baseline and 6 weeks. |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | 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. | Baseline and 3 months |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention. | 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. | 13 days to 259 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Affected by Death | Number of Participants affected by Death was reported | 90 days |
| Patients Who Had Amputations Following Initial Procedure. | Patients who went on to have amputations following initial procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Edwards, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilostazol | Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days |
| FG001 | Control | No Cilostazol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilostazol | Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days |
| BG001 | Control | No Cilostazol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | 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. | Only patients with data collected at each pair of time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks. |
|
90 days from surgery.
Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilostazol | Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amputation | Surgical and medical procedures | Non-systematic Assessment | Patients went on to have amputations after initial procedure. |
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The original principle investigator decided to terminate the study early in order to begin analysis due to his impending departure from Wake Forest Baptist Health.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Edwards | Wake Forest University Health Sciences | 336-716-9343 | medwards@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Oct 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline and Six Weeks |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | 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 |
| Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | 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 |
| Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | 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 |
| 90 days |
| Number of Participants Who Had a Stroke | Secondary outcome measure - patients who had a stroke during the 90 day follow up period. | 90 days |
| Claudication Symptoms and Rest Pain. | Secondary outcome measures including claudication symptoms and rest pain. | 90 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Cilostazol | Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days |
| OG001 | Control | No Cilostazol |
|
|
|
| Primary | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | 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. | Only patients with data collected at each pair of time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
|
| Primary | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | 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. | Only patients with data collected at each pair of time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Six Weeks |
|
|
|
|
| Primary | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | 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. | Only patients with data collected at each pair of time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
|
| Primary | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | 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. | Only patients with data collected at each pair of time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Six Weeks |
|
|
|
|
| Primary | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | 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. | Only patients with data collected at each pair of time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months |
|
|
|
|
| Secondary | Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention. | 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. | One patient had no scans to determine graft patency. | Posted | Count of Participants | Participants | 13 days to 259 days |
|
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|
|
| Other Pre-specified | Number of Participants Affected by Death | Number of Participants affected by Death was reported | Overall survival | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Other Pre-specified | Patients Who Had Amputations Following Initial Procedure. | Patients who went on to have amputations following initial procedure | Nineteen patients randomized to either Cilostazol or Control group who had lower extremity revascularization. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Other Pre-specified | Number of Participants Who Had a Stroke | Secondary outcome measure - patients who had a stroke during the 90 day follow up period. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Other Pre-specified | Claudication Symptoms and Rest Pain. | Secondary outcome measures including claudication symptoms and rest pain. | No data collected due to early termination of study. | Posted | No | 90 days |
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | No Cilostazol | 1 | 9 | 3 | 9 | 0 | 9 |
|
| Hemodialysis | Renal and urinary disorders | Non-systematic Assessment | Patient went on to diaysis |
|
| Other non-CVD | Renal and urinary disorders | Non-systematic Assessment | Renal Mass |
|
| Suspected MI | Cardiac disorders | Non-systematic Assessment | Patient expired from suspected myocardial infarction |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 3 Month Change Score |
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| 6 Week Change Score |
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| 3 Month Change Score |
|
| Change Score |
|
| 3 Month Change Score |
|