Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
調査の概要
詳細な説明
The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization.
Objectives: To demonstrate the superiority of the interventional management on top of optimal medical therapy over optimal medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization
Design : Multicenter, prospective randomized 1 :1, open-label blinded endpoint study
Target population : Heart transplant recipients, aged ≥18 years, without coronary artery disease-related symptoms, with angiographically significant coronary artery stenoses (≥50% anatomically adequate for a revascularization by coronary angioplasty with stent implantation, with no contraindication to dual antiplatelet therapy associating aspirin and a P2Y12 inhibitorfor a duration of 12 monthsand with ni grade IA ACC/AHA indication for revascularization
Inclusion period: 12 months (may be extended based on the inclusion rythme)
Maximum duration of participation for patients : 13 months
Total duration of the study : 37 months
Primary endpoint : The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitve ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline.The occurrence of any event qualifying for the primary endpoint will be assessed by a Cox survival analysis stratified on center.The primary endpoint will be assessed 12 months after randomization.
Secondary endpoints : Any of the individual events defining the primary outcome at 1 year
Number of patients to be included and power calculation : 80 patients per group. A 1 year primary endpoint rate of 30% in the active and 50% in with an inclusion period of 24 months and alpha=5% warants a 90% power using a cox model.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Paris、フランス、75013
- Pitié Salpetriere university Hospital - Cardiology
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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:
- Patients ≥ 18 years old
- Heart transplant recipient
- Stable clinical situation
- One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator
- Left ventricular ejection fraction ≥ 40%
- Informed consentement signed by the patient
Exclusion Criteria:
- Acute coronary syndrome
- In-stent restenosis
- Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)
- Coronary stenosis considered as critical by the operators with slow flow
ACC/AHA Class IA indication for revascularization :
- vessel disease with left ventricular dysfunction
- Left main stenosis
- Severe proximal LAD stenosis
- Contra-indication to dual antiplatelet therapy
- Decompensated heart failure at the time of randomization
- Pregnant or breast-feeding women- Patients participating to another clinical research within 30 days before randomization- life expectancy < 1 y
- Patients unable to observe strict medical therapy and follow-up within 1 year after randomization
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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実験的：1: Coronary stent+optimal medical therapy
Coronary stent on top of optimal medical therapy
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Coronary revascularization
他の名前：
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
他の名前：
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アクティブコンパレータ：2: Optimal medical therapy
Optimal medical therapy
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Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
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 |
|---|---|---|
|
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25%
時間枠：at 1 year
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The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year
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at 1 year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Death at 1 year
時間枠：at 1 year
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at 1 year
|
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myocardial infarction at 1 year
時間枠：at 1 year
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at 1 year
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Retransplantation at 1 year
時間枠：at 1 year
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at 1 year
|
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implantation of transitory or definitive ventricular assist devices at 1 year
時間枠：at 1 year
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at 1 year
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new or worsening heart failure at 1 year
時間枠：at 1 year
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at 1 year
|
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graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline
時間枠：at 1 year
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at 1 year
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協力者と研究者
捜査官
- スタディディレクター：Farzin BEYGUI, MD, PhD、Assistance Publique - Hôpitaux de Paris
- 主任研究者：Pascal LEPRINCE, MD, PhD、Assistance Publique - Hôpitaux de Paris
- 主任研究者：Saida VARNOUS, MD、Assistance Publique - Hôpitaux de Paris
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
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