Cilostazol After Lower Extremity Arterial Revascularization Trial

NCT02374957 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00030275
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Claudication (Finding)

Keywords

leg pain; claudication

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (1)

• Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.

  13 days to 259 days

Other Outcomes (4)

• Number of Participants Affected by Death

  90 days

• Patients Who Had Amputations Following Initial Procedure.

  90 days

• Number of Participants Who Had a Stroke

  90 days

Study Arms (2)

Cilostazol

ACTIVE COMPARATOR

Administer Cilostazol100 mg twice daily for 90 days.

Drug: Cilostazol

Control

NO INTERVENTION

No Cilostazol

Interventions

Cilostazol DRUG

100 mg twice daily for 90 days

Also known as: Pletal

Cilostazol

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 35 years of age
• Atherosclerotic peripheral arterial disease
• Able to provide informed consent
• Lower extremity open or endovascular revascularization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27106, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Signs and Symptoms

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and 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.

Results Point of Contact

• Title: Dr. Matthew Edwards
• Organization: Wake Forest University Health Sciences

medwards@wakehealth.edu

336-716-9343

Study Officials

• Matthew Edwards, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 2, 2015
• Study Start: February 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)