Cilostazol After Lower Extremity Arterial Revascularization Trial

Stopped early · Phase 4

Conditions studied: Peripheral Arterial Disease, Claudication (Finding)

In brief

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.

Key facts

Study ID

NCT02374957

Run by

Wake Forest University Health Sciences

People needed

20

Starts

2015-02-01

Expected to finish

2017-06-30

Last updated by the study team

2018-11-23

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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