Clinical trial NCT02374957: Cilostazol After Lower Extremity Arterial Revascularization Trial
Official title: Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Claudication (Finding)
Keywords: leg pain
claudication
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
timeFrame: Baseline and 6 weeks.
measure: Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.
timeFrame: Baseline and Six Weeks
measure: Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.
timeFrame: Baseline and 3 months
measure: Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
timeFrame: Baseline and Six Weeks
measure: Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
timeFrame: 13 days to 259 days
Other outcomes:
measure: Number of Participants Affected by Death
timeFrame: 90 days
measure: Patients Who Had Amputations Following Initial Procedure.
timeFrame: 90 days
measure: Number of Participants Who Had a Stroke
timeFrame: 90 days
measure: Claudication Symptoms and Rest Pain.
timeFrame: 90 days
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Matthew Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References: