Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus (OCELOT)
Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.
Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months.
Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12 months) of dual antiplatelet therapy
調査の概要
状態
詳細な説明
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
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Modena、イタリア、41100
- Azienda Policlinico-Universitaria di Modena
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Rome、イタリア、00100
- Policlinico Casilino
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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:
- Subject is > 18 years old
- Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent
- Subject and the treating physician agree that the subject will comply with all follow-up evaluations
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site
Exclusion Criteria:
- Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure
- The patient is pregnant or breastfeeding
- Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated)
- A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3
- Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- Prior participation in this study
- Active peptic ulcer or upper GI bleeding within the prior 3 months
- Subject has active sepsis
- Any lesion that is located in a saphenous vein graft
- In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study
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 |
|---|---|
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アクティブコンパレータ：Taxus Element
Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
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paclitaxel-eluting stent
他の名前：
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アクティブコンパレータ：Xience Prime
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
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Everolimus-eluting stent
他の名前：
|
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アクティブコンパレータ：Integrity Resolute
Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
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ABT 578-eluting stent
他の名前：
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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 |
|---|---|---|
|
Target lesion failure
時間枠：1 year
|
Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion
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1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effect of glucose levels on repeat revascularization
時間枠：1 year
|
Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
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1 year
|
|
Target Lesion Revascularization
時間枠：1, 2 and 3 year
|
Target lesion revascularization at 12, 24 and 36 months
|
1, 2 and 3 year
|
|
Effect of dual antiplatelet therapy on outcome
時間枠：3 year
|
Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome
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3 year
|
協力者と研究者
捜査官
- 主任研究者：Enrico Romagnoli, MD, PhD、Policlinico Casilino
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。