- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02374957
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forente stater, 27106
- Wake Forest Baptist Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
|
100 mg twice daily for 90 days
Andre navn:
|
Ingen inngripen: Control
No Cilostazol
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Affected by Death
Tidsramme: 90 days
|
Number of Participants affected by Death was reported
|
90 days
|
Patients Who Had Amputations Following Initial Procedure.
Tidsramme: 90 days
|
Patients who went on to have amputations following initial procedure
|
90 days
|
Number of Participants Who Had a Stroke
Tidsramme: 90 days
|
Secondary outcome measure - patients who had a stroke during the 90 day follow up period.
|
90 days
|
Claudication Symptoms and Rest Pain.
Tidsramme: 90 days
|
Secondary outcome measures including claudication symptoms and rest pain.
|
90 days
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Matthew Edwards, MD, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Aterosklerose
- Perifer arteriell sykdom
- Perifere vaskulære sykdommer
- Intermitterende Claudication
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Vasodilaterende midler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodplateaggregasjonshemmere
- Nevrobeskyttende midler
- Beskyttende agenter
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Fosfodiesterasehemmere
- Fosfodiesterase 3-hemmere
- Cilostazol
Andre studie-ID-numre
- IRB00030275
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Perifer arteriell sykdom
-
Mayo ClinicPåmelding etter invitasjonAnatomi av GSV for Rescue Peripheral IV AccessForente stater
-
Universitaire Ziekenhuizen KU LeuvenUniversity of Pittsburgh; Sheba Medical Center; Mount Sinai Hospital, Canada og andre samarbeidspartnereUkjentTwin Reversal Arterial Perfusion SyndromeSpania, Tyskland, Israel, Belgia, Nederland, Canada, Forente stater, Østerrike, Frankrike, Italia, Storbritannia
-
Lawson Health Research InstituteFullførtArteriosclerosis of arterial coronary artery bypass graftCanada
-
Deutsches Herzzentrum MuenchenFullførtArteriosclerosis of arterial coronary artery bypass graftTyskland
-
University of MiamiRekrutteringTvilling til tvillingtransfusjonssyndrom | Tvilling; Kompliserer graviditet | Twin Reversal Arterial Perfusion Syndrome | Monokorionisk diamniotisk placenta | Monokorial monoamniotisk placentaForente stater
-
Boston Children's HospitalHar ikke rekruttert ennåGraviditetsrelatert | Mors; Fremgangsmåte | Fosterets tilstander | Tvilling Monochorionic Monoamniotic Placenta | Tvilling til tvillingtransfusjonssyndrom | Twin Reversal Arterial Perfusion Syndrome | Vasa Previa | In utero-prosedyre som påvirker foster eller nyfødt | Chorion; Unormal | KorioangiomForente stater
Kliniske studier på Cilostazol
-
Kobe City General HospitalOsaka University; Okayama University; Kobe University; Nagoya University; Kyoto... og andre samarbeidspartnereFullførtIn-stent-restenose etter stenting av halspulsårenJapan
-
Beijing Tiantan HospitalNeuroDawn Pharmaceutical Co., Ltd.Har ikke rekruttert ennåAkutt iskemisk hjerneslag | Okklusjon av store fartøyer | Reperfusjon
-
Mutual Pharmaceutical Company, Inc.FullførtTerapeutisk ekvivalens
-
Mutual Pharmaceutical Company, Inc.FullførtTerapeutisk ekvivalens, sunn
-
University of EdinburghUniversity of Nottingham; British Heart FoundationFullførtCerebrale små karsykdommer | Hjerneslag, LacunarStorbritannia
-
Noorik Biopharmaceuticals AGAvsluttetCovid-19 | HypoksemiSpania, Kroatia
-
Otsuka Beijing Research InstituteFullført
-
Korea University Anam HospitalUkjentDiabetes mellitus, type 2 | Metabolsk syndrom XKorea, Republikken
-
Otsuka Pharmaceutical, Inc., PhilippinesFullført