- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02374957
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27106
- Wake Forest Baptist Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
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100 mg twice daily for 90 days
Andere Namen:
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Kein Eingriff: Control
No Cilostazol
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
Zeitfenster: Baseline and 6 weeks.
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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.
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Baseline and 6 weeks.
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months
Zeitfenster: 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
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Zeitfenster: 13 days to 259 days
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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.
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13 days to 259 days
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants Affected by Death
Zeitfenster: 90 days
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Number of Participants affected by Death was reported
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90 days
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Patients Who Had Amputations Following Initial Procedure.
Zeitfenster: 90 days
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Patients who went on to have amputations following initial procedure
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90 days
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Number of Participants Who Had a Stroke
Zeitfenster: 90 days
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Secondary outcome measure - patients who had a stroke during the 90 day follow up period.
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90 days
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Claudication Symptoms and Rest Pain.
Zeitfenster: 90 days
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Secondary outcome measures including claudication symptoms and rest pain.
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90 days
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Matthew Edwards, MD, Wake Forest University Health Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Atherosklerose
- Periphere arterielle Verschlusskrankheit
- Periphere Gefäßerkrankungen
- Schaufensterkrankheit
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Vasodilatator-Wirkstoffe
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Fibrinolytische Mittel
- Fibrinmodulierende Mittel
- Thrombozytenaggregationshemmer
- Neuroprotektive Wirkstoffe
- Schutzmittel
- Bronchodilatatoren
- Anti-Asthmatiker
- Atemwegsmittel
- Phosphodiesterase-Inhibitoren
- Phosphodiesterase-3-Inhibitoren
- Cilostazol
Andere Studien-ID-Nummern
- IRB00030275
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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