Assessment of Coronary Flow Reserve by Doppler Flow WIre in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Differences Between the Loading Dose of Prasugrel and Ticagrelor .
Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with acute coronary syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System.
Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. . In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:massimo mancone
- 電話番号:00390649979044
研究場所
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-
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Rome、イタリア、00100
- Massimo Mancone
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コンタクト:
- 電話番号:00390649970468
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主任研究者:
- massimo mancone
-
-
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 with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
- Patients ≥ 18 and ≤ 75 years old.
- Signed informed consent;
Exclusion Criteria:
• Patients with stable angina;
- prior myocardial infarction;
- prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
- Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
- Prasugrel contraindications (patients weighing less than 60 kg, patients who had previous stroke or transient ischemic attack, patients aged more than 75 years old);
- major periprocedural complications;
- suboptimal Percutaneous Coronary Intervention result (residual stenosis > 20%);
- glomerular filtration rate < 30 ml/min or requiring haemodialysis;
- Non-sinus rhythm;
- severe chronic obstructive pulmonary disease;
- requirement for oral anticoagulant;
- risk of bleeding or bradycardic events;
- ejection fraction < 45%;
- Cardiogenic shock;
- Severe left ventricular hypertrophy;
- severe valvular disease;
- diffuse coronary atherosclerosis;
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:基礎科学
- 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:Ticagrelor
Patient randomized to Ticagrelor
|
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アクティブコンパレータ:Prasugrel
Patient randomized to Prasugrel
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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 |
時間枠 |
---|---|
assessment of coronary flow reserve
時間枠:2 hours after the loading dose
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2 hours after the loading dose
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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。
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