Trial Outcomes & Findings for Cilostazol After Lower Extremity Arterial Revascularization Trial (NCT NCT02374957)

NCT ID: NCT02374957

Last Updated: 2018-11-23

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 6 weeks.
• Results posted on: 2018-11-23

Participant Flow

Participant milestones

Measure	Cilostazol Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control No Cilostazol
Overall Study STARTED	11	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Cilostazol Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control No Cilostazol
Overall Study Patient did not complete forms correctly	1	0

Baseline Characteristics

Cilostazol After Lower Extremity Arterial Revascularization Trial

Baseline characteristics by cohort

Measure	Cilostazol n=10 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=9 Participants No Cilostazol	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	63.60 years n=5 Participants	63.11 years n=7 Participants	63.37 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks.

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

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.

Outcome measures

Measure	Cilostazol n=9 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=7 Participants No Cilostazol
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks Baseline	14.00 score on a scale Standard Deviation 4.00	15.57 score on a scale Standard Deviation 2.94
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks Six Weeks	12.89 score on a scale Standard Deviation 3.33	12.14 score on a scale Standard Deviation 4.53
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks Six Week Change Score	1.11 score on a scale Standard Deviation 3.89	3.43 score on a scale Standard Deviation 3.95

PRIMARY outcome

Timeframe: Baseline and 3 months

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

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.

Outcome measures

Measure	Cilostazol n=8 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=6 Participants No Cilostazol
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months Baseline	14.50 score on a scale Standard Deviation 4.07	16.17 score on a scale Standard Deviation 2.71
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months Three Months	13.75 score on a scale Standard Deviation 4.62	12.50 score on a scale Standard Deviation 3.21
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months 3 Month Change Score	0.75 score on a scale Standard Deviation 3.77	3.67 score on a scale Standard Deviation 3.50

PRIMARY outcome

Timeframe: Baseline and Six Weeks

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

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.

Outcome measures

Measure	Cilostazol n=9 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=7 Participants No Cilostazol
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. Baseline	61.67 score on a scale Standard Deviation 17.32	42.86 score on a scale Standard Deviation 22.33
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. Six Weeks	60.00 score on a scale Standard Deviation 24.37	71.43 score on a scale Standard Deviation 23.40
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. 6 Week Change Score	-1.67 score on a scale Standard Deviation 21.94	28.57 score on a scale Standard Deviation 27.04

PRIMARY outcome

Timeframe: Baseline and 3 months

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

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.

Outcome measures

Measure	Cilostazol n=8 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=6 Participants No Cilostazol
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. Baseline	57.50 score on a scale Standard Deviation 13.89	41.67 score on a scale Standard Deviation 24.22
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. Three Months	47.50 score on a scale Standard Deviation 21.88	65.83 score on a scale Standard Deviation 28.00
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. 3 Month Change Score	-10.00 score on a scale Standard Deviation 14.14	24.17 score on a scale Standard Deviation 29.73

PRIMARY outcome

Timeframe: Baseline and Six Weeks

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

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.

Outcome measures

Measure	Cilostazol n=9 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=7 Participants No Cilostazol
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks Six Weeks	13.78 score on a scale Standard Deviation 9.20	11.71 score on a scale Standard Deviation 7.91
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks Change Score	-3.33 score on a scale Standard Deviation 12.04	-4.71 score on a scale Standard Deviation 11.51
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks Baseline	17.11 score on a scale Standard Deviation 8.82	16.43 score on a scale Standard Deviation 10.91

PRIMARY outcome

Timeframe: Baseline and 3 months

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

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.

Outcome measures

Measure	Cilostazol n=8 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=6 Participants No Cilostazol
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months Three Months	15.25 score on a scale Standard Deviation 18.91	13.00 score on a scale Standard Deviation 10.94
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months 3 Month Change Score	1.88 score on a scale Standard Deviation 17.01	-2.50 score on a scale Standard Deviation 12.83
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months Baseline	13.38 score on a scale Standard Deviation 9.15	15.50 score on a scale Standard Deviation 11.64

SECONDARY outcome

Timeframe: 13 days to 259 days

Population: One patient had no scans to determine graft patency.

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.

Outcome measures

Measure	Cilostazol n=10 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=8 Participants No Cilostazol
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: Overall survival

Number of Participants affected by Death was reported

Outcome measures

Measure	Cilostazol n=10 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=9 Participants No Cilostazol
Number of Participants Affected by Death	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

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

Patients who went on to have amputations following initial procedure

Outcome measures

Measure	Cilostazol n=10 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=9 Participants No Cilostazol
Patients Who Had Amputations Following Initial Procedure.	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

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

Outcome measures

Measure	Cilostazol n=10 Participants Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=9 Participants No Cilostazol
Number of Participants Who Had a Stroke	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: No data collected due to early termination of study.

Secondary outcome measures including claudication symptoms and rest pain.

Outcome measures

Outcome data not reported

Adverse Events

Cilostazol

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cilostazol n=10 participants at risk Administer Cilostazol100 mg twice daily for 90 days. Cilostazol: 100 mg twice daily for 90 days	Control n=9 participants at risk No Cilostazol
Surgical and medical procedures Amputation	10.0% 1/10 • Number of events 1 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.	22.2% 2/9 • Number of events 2 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.
Renal and urinary disorders Hemodialysis	10.0% 1/10 • Number of events 1 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.	11.1% 1/9 • Number of events 1 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.
Renal and urinary disorders Other non-CVD	10.0% 1/10 • Number of events 1 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.	0.00% 0/9 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.
Cardiac disorders Suspected MI	0.00% 0/10 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.	11.1% 1/9 • Number of events 1 • 90 days from surgery. Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Edwards

Wake Forest University Health Sciences

Phone: 336-716-9343

Email: medwards@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place