Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27106
- Wake Forest Baptist Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Cilostazol
Administer Cilostazol100 mg twice daily for 90 days.
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100 mg twice daily for 90 days
他の名前:
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介入なし:Control
No Cilostazol
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
時間枠: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
時間枠: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.
|
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.
時間枠: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.
時間枠: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
時間枠:Baseline and Six Weeks
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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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
時間枠: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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Participants Affected by Death
時間枠: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.
時間枠: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
時間枠: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.
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Matthew Edwards, MD、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00030275
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末梢動脈疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ