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Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)

21 november 2018 bijgewerkt door: Wake Forest University Health Sciences

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Winston-Salem, North Carolina, Verenigde Staten, 27106
        • Wake Forest Baptist Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
Geneesmiddel: Cilostazol
100 mg twice daily for 90 days
Andere namen:
  • Pletaal
Geen tussenkomst: Control
No Cilostazol

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
Tijdsspanne: Baseline and 6 weeks.
The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.
Baseline and 6 weeks.
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months
Tijdsspanne: Baseline and 3 months
The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. . The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.
Baseline and 3 months
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.
Tijdsspanne: Baseline and Six Weeks

The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.

Higher numbers are better.
Baseline and Six Weeks
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.
Tijdsspanne: Baseline and 3 months

The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.

Higher numbers are better.
Baseline and 3 months
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
Tijdsspanne: Baseline and Six Weeks

The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.

With the EACH-Q higher scores are better.
Baseline and Six Weeks
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months
Tijdsspanne: Baseline and 3 months

The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.

With the EACH-Q higher scores are better.
Baseline and 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Tijdsspanne: 13 days to 259 days
Graft patency was determined by duplex scan as opened or occluded. Follow-up duplex testing ranged from 13 days to 259 days. Number of patency failures (i.e., graft occlusions) are shown below by treatment arm.
13 days to 259 days

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Affected by Death
Tijdsspanne: 90 days
Number of Participants affected by Death was reported
90 days
Patients Who Had Amputations Following Initial Procedure.
Tijdsspanne: 90 days
Patients who went on to have amputations following initial procedure
90 days
Number of Participants Who Had a Stroke
Tijdsspanne: 90 days
Secondary outcome measure - patients who had a stroke during the 90 day follow up period.
90 days
Claudication Symptoms and Rest Pain.
Tijdsspanne: 90 days
Secondary outcome measures including claudication symptoms and rest pain.
90 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Onderzoekers

  • Hoofdonderzoeker: Matthew Edwards, MD, Wake Forest University Health Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2015

Primaire voltooiing (Werkelijk)

30 juni 2017

Studie voltooiing (Werkelijk)

30 juni 2017

Studieregistratiedata

Eerst ingediend

10 februari 2015

Eerst ingediend dat voldeed aan de QC-criteria

23 februari 2015

Eerst geplaatst (Schatting)

2 maart 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 november 2018

Laatste update ingediend die voldeed aan QC-criteria

21 november 2018

Laatst geverifieerd

1 november 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00030275

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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