Peripheral Arterial Disease Clinical Trial
Official title:
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
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.
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.
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