Cilostazol After Lower Extremity Arterial Revascularization Trial

• Status: Terminated
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Cilostazol

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.