CLEAR: Cilostazol After Lower Extremity Arterial Revascularization Trial

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02374957
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 28.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease; Claudication (Finding)	Drug: Cilostazol	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cilostazol Administer Cilostazol100 mg twice daily for 90 days.	Drug: Cilostazol; 100 mg twice daily for 90 days; Other Names: Pletal
No Intervention: Control No Cilostazol

Outcome Measures

Primary Outcome Measures

1. Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks [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.

2. Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months [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.

3. Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. [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.

4. Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. [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.

5. Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks [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.

6. Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months [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.

Secondary Outcome Measures

1. Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention. [13 days to 259 days]

   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.

Other Outcome Measures

1. Number of Participants Affected by Death [90 days]

   Number of Participants affected by Death was reported

2. Patients Who Had Amputations Following Initial Procedure. [90 days]

   Patients who went on to have amputations following initial procedure

3. Number of Participants Who Had a Stroke [90 days]

   Secondary outcome measure - patients who had a stroke during the 90 day follow up period.

4. Claudication Symptoms and Rest Pain. [90 days]

   Secondary outcome measures including claudication symptoms and rest pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27106

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Matthew Edwards, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 24, 2018

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02374957
• Other Study ID Numbers: IRB00030275
• First Posted: Mar 2, 2015
• Last Update Posted: Nov 23, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: leg pain; claudication
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Cilostazol

Study Results

Participant Flow

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Period Title: Overall Study
STARTED	11	9
COMPLETED	10	9
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Cilostazol	Control	Total
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol	Total of all reporting groups
Overall Participants	10	9	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 40%	3 33.3%	7 36.8%
>=65 years	6 60%	6 66.7%	12 63.2%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.60	63.11	63.37
Sex: Female, Male (Count of Participants)
Female	4 40%	2 22.2%	6 31.6%
Male	6 60%	7 77.8%	13 68.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 11.1%	1 5.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 50%	4 44.4%	9 47.4%
White	5 50%	4 44.4%	9 47.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
Description	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.
Time Frame	Baseline and 6 weeks.

Outcome Measure Data

Analysis Population Description

Only patients with data collected at each pair of time points are included in the analysis.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	9	7
Baseline	14.00 (4.00)	15.57 (2.94)
Six Weeks	12.89 (3.33)	12.14 (4.53)
Six Week Change Score	1.11 (3.89)	3.43 (3.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: six-week change in EQ5D sum score is the same between the two arms. Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Only patients with data collected at each pair of time points are included in the analysis.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	8	6
Baseline	14.50 (4.07)	16.17 (2.71)
Three Months	13.75 (4.62)	12.50 (3.21)
3 Month Change Score	0.75 (3.77)	3.67 (3.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: three-month change in EQ5D sum score is the same between the two arms. Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.
Description	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.
Time Frame	Baseline and Six Weeks

Outcome Measure Data

Analysis Population Description

Only patients with data collected at each pair of time points are included in the analysis.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	9	7
Baseline	61.67 (17.32)	42.86 (22.33)
Six Weeks	60.00 (24.37)	71.43 (23.40)
6 Week Change Score	-1.67 (21.94)	28.57 (27.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms. Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Only patients with data collected at each pair of time points are included in the analysis.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	8	6
Baseline	57.50 (13.89)	41.67 (24.22)
Three Months	47.50 (21.88)	65.83 (28.00)
3 Month Change Score	-10.00 (14.14)	24.17 (29.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms. Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
Description	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.
Time Frame	Baseline and Six Weeks

Outcome Measure Data

Analysis Population Description

Only patients with data collected at each pair of time points are included in the analysis.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	9	7
Baseline	17.11 (8.82)	16.43 (10.91)
Six Weeks	13.78 (9.20)	11.71 (7.91)
Change Score	-3.33 (12.04)	-4.71 (11.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: six-week change in EACH Q sum score is the same between the two arms. Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	t-test, 2 sided
	Comments

6. Primary Outcome

Title	Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Only patients with data collected at each pair of time points are included in the analysis.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	8	6
Baseline	13.38 (9.15)	15.50 (11.64)
Three Months	15.25 (18.91)	13.00 (10.94)
3 Month Change Score	1.88 (17.01)	-2.50 (12.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: three-month change in EACH Q sum score is the same between the two arms. Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Description	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.
Time Frame	13 days to 259 days

Outcome Measure Data

Analysis Population Description

One patient had no scans to determine graft patency.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	10	8
Count of Participants [Participants]	3 30%	2 22.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cilostazol, Control
	Comments	Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms. Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	Log Rank
	Comments

8. Other Pre-specified Outcome

Title	Number of Participants Affected by Death
Description	Number of Participants affected by Death was reported
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Overall survival

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	10	9
Count of Participants [Participants]	0 0%	1 11.1%

9. Other Pre-specified Outcome

Title	Patients Who Had Amputations Following Initial Procedure.
Description	Patients who went on to have amputations following initial procedure
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Nineteen patients randomized to either Cilostazol or Control group who had lower extremity revascularization.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	10	9
Count of Participants [Participants]	1 10%	2 22.2%

10. Other Pre-specified Outcome

Title	Number of Participants Who Had a Stroke
Description	Secondary outcome measure - patients who had a stroke during the 90 day follow up period.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	10	9
Count of Participants [Participants]	0 0%	0 0%

11. Other Pre-specified Outcome

Title	Claudication Symptoms and Rest Pain.
Description	Secondary outcome measures including claudication symptoms and rest pain.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

No data collected due to early termination of study.

Arm/Group Title	Cilostazol	Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	No Cilostazol
Measure Participants	0	0

Adverse Events

Time Frame	90 days from surgery.
Adverse Event Reporting Description	Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.
Arm/Group Title	Cilostazol		Control
Arm/Group Description	Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days		No Cilostazol
All Cause Mortality
	Cilostazol		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/9 (11.1%)
Serious Adverse Events
	Cilostazol		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		3/9 (33.3%)
Cardiac disorders
Suspected MI	0/10 (0%)	0	1/9 (11.1%)	1
Renal and urinary disorders
Hemodialysis	1/10 (10%)	1	1/9 (11.1%)	1
Other non-CVD	1/10 (10%)	1	0/9 (0%)	0
Surgical and medical procedures
Amputation	1/10 (10%)	1	2/9 (22.2%)	2
Other (Not Including Serious) Adverse Events
	Cilostazol		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/9 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.