Cilostazol After Lower Extremity Arterial Revascularization Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Claudication (Finding)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cilostazol

Administer Cilostazol100 mg twice daily for 90 days.

Group Type ACTIVE_COMPARATOR

Cilostazol

Intervention Type DRUG

100 mg twice daily for 90 days

Control

No Cilostazol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cilostazol

100 mg twice daily for 90 days

Intervention Type DRUG

Other Intervention Names

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Pletal

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No