Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy

Официальное название

Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized Trial

Обзор

This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.

Подробное описание

Bivalirudin is a direct thrombin inhibitor that exhibits a reversible and transient anticoagulant effect. Randomized trials have shown conflicting results for bivalirudin in reducing the risk of bleeding for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI (PPCI) compared to heparin. Recently, the BRIGHT-4 study, which assigned 6016 STEMI patients to bivalirudin with a prolonged high dose infusion or heparin during PPCI, showed bivalirudin decreased the risk of a composite endpoint of all-cause mortality and bleeding. However, few studies have focused on the safety and efficacy of bivalirudin in PCI post-fibrinolysis. We therefore aim to conduct the Bivalirudin With Prolonged Infusion During PCI Versus Heparin Following Fibrinolytic Therapy (BRIGHT-FIT) trial to examine whether bivalirudin with a high-dose infusion in PCI after fibrinolysis in superior to heparin in reducing mortality and major bleeding.

Вмешательства

• Препарат Bivalirudin
  For rescued PCI, do not recommend to include patient who's ACT is more than 350s. If fibrinolysis is successful, monitor ACT and wait till it's lower than 350s before randomization. Monitor ACT before angiography, (1) if ACT\<180, bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI; (2) if 180s\<ACT\<225s, bivalirudin 0.5mg/kg intravenous bolus loading dose, and immediately followed by intravenous inf
• Препарат Unfractionated heparin
  (1)If ACT\<180s, administer an intravenous bolus of unfractionated heparin at 70 U/kg before coronary angiography, with a maximum total dose of 6000U. (2)If 180\<ACT\<225s, administer an intravenous bolus of unfractionated heparin at 60 U/kg before coronary angiography, with a maximum total dose of 4000U. (3)If ACT\>225s, proceed directly with PCI and maintain 225s\<ACT\<350s.

Первичные конечные точки

• Composite of all-cause death or BARC type 3、5 bleeding [Срок оценки: 30days]

Вторичные конечные точки (8)

• All cause mortality [Срок оценки: 30days and 1year]
• Composite of all-cause death or BARC type 2、3、5 bleeding [Срок оценки: 30days and 1year]
• Net adverse clinical events (NACE) [Срок оценки: 30days and 1year]
• Major adverse cardiac and cerebral events (MACCE) [Срок оценки: 30days and 1year]
• Stent thrombosis [Срок оценки: 30days]
• BARC type 3、5 bleeding [Срок оценки: 30days]
• BARC type 2、3、5 bleeding [Срок оценки: 30days]
• Thrombocytopenia [Срок оценки: 30days]

Критерии участия

Критерии включения

• Any age
• STEMI patients received fibrinolysis therapy within 12h of symptom onset and are planned to undergo PCI within 24h of symptom onset.
• Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor)
• Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
• The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Критерии исключения

• Not suitable for PCI;
• Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
• Cardiogenic shock(Killip IV)
• Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
• Patients who underwent PCI in past 30 days
• Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study, pregnancy).

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06861374 · XJTU1AF2024LSYY-321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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