Cilostazol After Lower Extremity Arterial Revascularization Trial
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral Arterial Disease; Claudication (Finding)
Intervention: Cilostazol (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Wake Forest School of Medicine Official(s) and/or principal investigator(s): Nitin Garg, MD, Principal Investigator, Affiliation: Wake Forest Baptist Health
Overall contact: Nitin Garg, MD, Phone: 336-716-9502, Email: ngarg@wakehealth.edu
Summary
Ten patients will be recruited to CLEAR. Five will be randomized to the treatment arm
(Cilostazol) and five will 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.
Clinical Details
Official title: Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Difference in quality of life in relation to use of cilostazol after lower extremity revascularization
Secondary outcome: Patency of the graft/stent and re intervention rate after initial procedure
Detailed description:
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. Ten patients will be recruited and randomized; 5 to the treatment group and 5 to
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.
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Nitin Garg, MD, Phone: 336-716-9502, Email: ngarg@wakehealth.edu Additional Information
Starting date: February 2015
Last updated: February 23, 2015
|