- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374957
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27106
- Wake Forest Baptist Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
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100 mg twice daily for 90 days
Other Names:
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No Intervention: Control
No Cilostazol
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: Baseline and 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.
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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
Time Frame: Baseline and 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.
Time Frame: Baseline and Six 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. |
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.
Time Frame: Baseline and 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
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Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
Time Frame: Baseline and Six 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
Time Frame: Baseline and 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Affected by Death
Time Frame: 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.
Time Frame: 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
Time Frame: 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.
Time Frame: 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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Collaborators and Investigators
Investigators
- Principal Investigator: Matthew Edwards, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Intermittent Claudication
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Neuroprotective Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Phosphodiesterase 3 Inhibitors
- Cilostazol
Other Study ID Numbers
- IRB00030275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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