Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery (MONET)
2018年11月12日 更新者:Italian Society of Invasive Cardiology
The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure.
The effects of the application of the Consensus Document "Stent and Surgery-2" on perioperative antiplatelet therapy will be assessed.
The study will also assess ischemic and hemorrhagic events in relation to the application of the Consensus Document and length of any antiplatelet discontinuation and delay in performing surgical procedures.
調査の概要
状態
わからない
条件
詳細な説明
The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers.
Centers will be divided into two groups: Centers that routinely follow the recommendations of the SAS 2 Document and Centers that do not.
The relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF).
The primary endpoint will be the rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy.
The secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from PCI to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from PCI divided into quartiles (0-3, 3-6, 6-9, 9-12 months).
研究の種類
観察的
入学 (予想される)
1800
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cosenza、イタリア
- A.O. di Cosenza
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Roma、イタリア、00128
- Università Campus Bio-Medico di Roma
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CN
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Cuneo、CN、イタリア、12100
- A.O. Santa Croce e Carle di Cuneo
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MI
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Rozzano、MI、イタリア、20089
- Istituto Clinico Humanitas
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TO
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Rivoli、TO、イタリア、10098
- Ospedale Degli Infermi
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients with prior percutaneous coronary intervention (PCI) with stent implantation undergoing urgent or elective surgical/endoscopic procedures
説明
Inclusion Criteria:
- Eligible will be male and female patients > 18 years of age.
- Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
- Both candidates to elective and urgent/emergent surgical procedures will be included in the MONET registry.
Exclusion Criteria:
- Unwillingness/inability to sign the Informed Consent Form (ICF). Patients with an active bleeding requiring discontinuation of one or both antiplatelet agents will be also excluded. There are no other exclusion criteria.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
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 |
---|---|---|
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
時間枠:3 months
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Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy
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3 months
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Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
時間枠:6 months
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Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Giuseppe Musumeci, MD、A.O. Santa Croce e Carle di Cuneo, 26 - 12100 - Cuneo (CN)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2018年11月21日
一次修了 (予想される)
2019年2月21日
研究の完了 (予想される)
2019年11月20日
試験登録日
最初に提出
2018年2月16日
QC基準を満たした最初の提出物
2018年2月22日
最初の投稿 (実際)
2018年2月26日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月14日
QC基準を満たした最後の更新が送信されました
2018年11月12日
最終確認日
2018年7月1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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