Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery

Официальное название

Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery: A Prospective, Multicenter, Randomized Study Comparing Two Durations of Dual Antiplatelet Therapy

Обзор

Coronary arteries are in charge of oxygen supply for the myocardium. When coronary arteries develop stenosis the coronary blood flow (i.e. oxygen flow) is reduced. Chronic total occlusion (CTO) is the extreme evolution of a coronary stenosis, which ends up to a total vessel closure. Percutaneous coronary intervention (PCI) is the main treatment for chronic occlusions. The principle of this treatment is to implant a stent covering the whole segment of occlusion and allowing the blood to perfuse the myocardium antegradely and not retrogradely via the collateral(s). This angioplasty and stent implantation requires a dual antiplatelet therapy (aspirin associated with clopidogrel) to prevent a new thrombosis within the newly placed coronary stent. Following the development of coronary stent (and particularly drug eluting coronary stent) new thrombosis within the implanted coronary scaffold have emerged. Dual antiplatelet therapy (DAPT) (compared to single antiplatelet therapy or anticoagulant) and initially prolonged DAPT (12 months) has offered a preventive treatment for stent thrombosis after PCI. PCI treatment for CTOs continues to increase in France and around the world, while no dedicated study has been proposed so far regarding DAPT duration. Therefore, the general European recommendations for DAPT in chronic coronary syndrome management guidelines should be applied even though the CTO poses specific technical challenges (long and multiple stenting length for example). Even if 6 months DAPT is recommended as routine duration in chronic coronary syndrome (CCS), longer DAPT (12 months) is possible in this setting. However, the optimal duration of DAPT is not clearly demonstrated on an individual basis and each physician must adapt the DAPT duration for each single patient. A so called "ischemic / bleeding balance "guides the duration of DAPT. This study would be the first randomized protocol to clarify the efficacy and safety of a shorter DAPT duration in the specific context of CTO PCI. It is conceivable that the technical advances which have made it possible to reduce the duration of DAPT to up to 1 month, in the cases of patients at high risk of bleeding for example, could be applicable to CTO PCI. Therefore, reducing the DAPT to 1 month, in the setting of CTO PCI, could reduce the haemorrhagic risk which should be proportional to the duration of the DAPT. Moreover, the invesitgators will evaluate the safety of short DAPT in terms of ischemic events during follow-up.

Вмешательства

• Процедура Percutaneous coronary intervention
  A percutaneous coronary intervention for chronic total occlusion lesion with at least one implanted coronary stent will be performed as part of routine care.
• Препарат Short dual Aspirin/Clopidogrel therapy
  Aspirin will be prescribed as part of the patient's normal course of care, according to current recommendations. The second antiplatelet agent will be clopidogrel, the duration of which will vary according to the randomization group of each patient included. Patients will be treated for 1 month.
• Другое Long dual Aspirin/Clopidogrel therapy
  Aspirin will be prescribed as part of the patient's normal course of care, according to current recommendations. The second antiplatelet agent will be clopidogrel, the duration of which will vary according to the randomization group of each patient included. Patients will be treated for 6 to 12 months.
• Другое Follow-up visit at 1 month
  At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.
• Другое Follow-up visit at 6 months
  At 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.
• Другое Follow-up visit at 12 months
  At 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.

Первичные конечные точки

• bleeding events at 12 months [Срок оценки: 12 months]
• ischemic events at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Major adverse ischemic clinical events (MACE) [Срок оценки: 12 months]
• Time-to-bleeding [Срок оценки: 12 months]
• Time-to-all cause death [Срок оценки: 12 months]
• Compliance to drug regimen at 1 month [Срок оценки: 1 month]
• Compliance to drug regimen at 6 months [Срок оценки: 6 months]
• Compliance to drug regimen at 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients who underwent a successful coronary stent implantation for chronic coronary occlusion, eligible for long-term aspirin therapy and requiring a dual antiplatelet therapy
• Affiliated to Social Security system.
• Signature of informed consent.
• Age > 18 years old.

Критерии исключения

• Dual antiplatelet therapy contra-indication
• Patient with hypersensitivity to aspirin (or any of its excipients) and/or to any of the active substance or to any of the excipients of the investigational medical product used in this study (clopidogrel);
• Patient with contraindication to aspirin and/or clopidogrel.
• No coronary stent implanted
• Age < 18years
• Patient under guardianship
• Pregnancy or breast feeding
• Prasugrel or ticagrelor use

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06175377 · RCAPHM23_0327

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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