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- Ensaio Clínico NCT02374957
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27106
- Wake Forest Baptist Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
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100 mg twice daily for 90 days
Outros nomes:
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Sem intervenção: Control
No Cilostazol
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
Prazo: 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
Prazo: Baseline and 3 months
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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 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.
Prazo: 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
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Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.
Prazo: 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
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Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
Prazo: 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
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Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants Affected by Death
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matthew Edwards, MD, Wake Forest University Health Sciences
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Doenças Vasculares
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Aterosclerose
- Doença arterial periférica
- Doenças Vasculares Periféricas
- Claudicação Intermitente
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Vasodilatadores
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Agentes Fibrinolíticos
- Agentes Moduladores de Fibrina
- Inibidores da agregação plaquetária
- Agentes Neuroprotetores
- Agentes de proteção
- Agentes broncodilatadores
- Agentes Antiasmáticos
- Agentes do Sistema Respiratório
- Inibidores da fosfodiesterase
- Inibidores da Fosfodiesterase 3
- Cilostazol
Outros números de identificação do estudo
- IRB00030275
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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Ensaios clínicos em Doença arterial periférica
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Mayo ClinicInscrevendo-se por conviteAnatomia da GSV para Rescue Peripheral IV AccessEstados Unidos
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Dartmouth-Hitchcock Medical CenterDartmouth CollegeConcluídoPressão arterial | Anestesia | Linha arterialEstados Unidos
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BLZ Technology (Wuhan) Co.,LtdAinda não está recrutandoPressão arterial | Anestesia geral | Linha arterial | Pulsação
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AHEPA University HospitalConcluídoRigidez Arterial | Monitorização Ambulatorial da Pressão ArterialGrécia
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Auburn UniversityAtivo, não recrutandoDorme | Pressão arterial | Disfunção Endotelial | Racismo | Rigidez ArterialEstados Unidos
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Unity Health TorontoConcluídoRigidez Arterial, Pressão ArterialCanadá
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Istituto Auxologico ItalianoRecrutamentoHipertensão arterial | Monitorização Ambulatorial da Pressão Arterial | Determinação da pressão arterial | Monitoramento residencial da pressão arterialItália
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ROX Medical, Inc.ConcluídoHipertensão | Pressão Arterial, Alta | Pressão Arterial, Resistente | Pressão Arterial, DescontroladaReino Unido, Holanda, Bélgica
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DongGuk UniversityAtivo, não recrutandoHipertensão | Pressão arterial | Pressão Arterial Ambulatorial | Medição de pressão arterial em casaRepublica da Coréia
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University of JyvaskylaBusiness Finland; Finnish Foundation for Cardiovascular Research; Harvia Finland...ConcluídoPressão arterial | Fator de Risco Cardiovascular | Rigidez ArterialFinlândia
Ensaios clínicos em Cilostazol
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Kobe City General HospitalOsaka University; Okayama University; Kobe University; Nagoya University; Kyoto University e outros colaboradoresConcluídoReestenose intra-stent após colocação de stent na artéria carótidaJapão
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Mutual Pharmaceutical Company, Inc.ConcluídoEquivalência Terapêutica
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Mutual Pharmaceutical Company, Inc.ConcluídoEquivalência Terapêutica, Saudável
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Beijing Tiantan HospitalNeuroDawn Pharmaceutical Co., Ltd.Ainda não está recrutandoAVC Isquêmico Agudo | Oclusão de Vasos Grandes | Reperfusão
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Noorik Biopharmaceuticals AGRescindidoCovid19 | HipoxemiaEspanha, Croácia
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University of EdinburghUniversity of Nottingham; British Heart FoundationConcluídoDoenças Cerebrais de Pequenos Vasos | AVC, LacunarReino Unido
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Otsuka Beijing Research InstituteConcluído
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Korea University Anam HospitalDesconhecidoDiabetes Mellitus, Tipo 2 | Síndrome Metabólica XRepublica da Coréia
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Genovate Biotechnology Co., Ltd.,RescindidoClaudicação IntermitenteEstados Unidos