Cilostazol After Lower Extremity Arterial Revascularization Trial

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.

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.