Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 29
- 主要终点
- Primary Laboratory endpoint
研究概览
简要总结
Multicenter, international, randomized, placebo-controlled, double-blind trial comparing intravenous cangrelor and crushed oral ticagrelor in patients with acute myocardial infarction complicated by initial cardiogenic shock (CS-AMI) and treated with primary angioplasty (PCI).
The Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction (DAPT-SHOCK-AMI) trial tests the hypothesis that intravenous cangrelor is (a) more effective in terms of its rate of onset and the proportion of patients achieving effective periprocedural inhibition of ADP-induced platelet aggregation and (b) at least as effective as the recommended treatment of oral (crushed) ticagrelor in reducing major cardiovascular events in patients with initial CS-AMI indicated for primary PCI strategy.
详细描述
Randomization to study drugs will be performed using an online database system for data collection. After entering basic patient data, the assigned arm and the randomization code will be generated based on a predefined randomization scheme.
Concomitant therapy includes acetylsalicylic acid: an initial intravenous dose of 500 mg, followed by a daily oral dose of 100 mg. A proton pump inhibitor is also recommended. Additional therapies, such as further antithrombotic treatments (e.g., GP IIb/IIIa inhibitors, heparin) and mechanical support (IABP, ECMO), remain fully within the competence of the treating physician.
Electronic database - eCRF. The data from individual follow-up assessments will be entered into an electronic database. The online instrument CLADE-IS will be used for data collection; this instrument provides robust options for electronic case report form (eCRF) design, hierarchical administration of user rights and a user-friendly web interface. The system provides predefined validation rules, conversions of variables, and it considers the relationships between variables; user access is controlled by the hierarchical system of user rights and user roles, and database operations are stored for audits and tracking of changes. Data safety is ensured through physical security of the servers, authorized access, and backup procedures.
Laboratory collections. The efficacy of the antiplatelet drugs cangrelor and ticagrelor will be determined using flow cytometry analysis of intracellular VASP (vasodilator-stimulated phosphoprotein) phosphorylation.
Study Committees: Executive c., Steering c., Endpoint adjudication c., Data safety monitoring board.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Acute myocardial infarction according to the definition of ESC/ACC/AHA, indicated for emergency percutaneous coronary intervention (primary PCI strategy)
- •Cardiogenic shock present upon admission due to the AMI (≥ 2 of the criteria below are satisfied)
- •sBP < 90 mmHg with the absence of hypovolemia
- •Need of vasopressor and/or inotropic therapy
- •Presence of the signs of the organ hypoperfusion - cyanosis, cold acra, disorder of consciousness, congestive heart failure
- •Informed consent form signed
- •Women of childbearing potential should be protected from pregnancy throughout the study (relevant for long-term use of ticagrelor). Suitable methods of contraception in this case include hormonal contraceptives, barrier methods, or complete withdrawal - as long as it is consistent with the patient's lifestyle.
排除标准
- •Contraindications of antiplatelet therapy with ticagrelor/cangrelor
- •Recent (< 6 months) major bleeding
- •Recent (< 1 month) major surgery/injury
- •History of intracranial bleeding
- •History of stroke/TIA
- •Known intolerance to ticagrelor/cangrelor
- •Severe impairment of hepatic function
- •Concomitant administration of strong CYP3A4 inhibitors (for example, ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
- •Administration of a loading dose of an oral P2Y12 inhibitor prior to admission (clopidogrel ≥ 300 mg, ticagrelor 180 mg, prasugrel 60 mg)
- •Need of concomitant chronic anticoagulation therapy due to indications such as atrial fibrillation, artificial valve, thromboembolic disease, etc.
研究组 & 干预措施
Cangrelor therapy
IV Cangrelor is initiated immediately after the patient arrives at the 24/7 PCI center (cathlab, coronary/intensive care unit, other parts of department) and is randomized to the study.
干预措施: Cangrelor (Drug)
Ticagrelor therapy
The patient will receive the initial dose of crushed Ticagrelor immediately after arriving at the 24/7 PCI center (cath lab, coronary/intensive care unit, other parts of the department) and after being randomly assigned to the study; in patients with a disorder of consciousness, the initial dose will be administered immediately after the nasogastric tube is inserted.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Primary Laboratory endpoint
时间窗: At the end of primary percutaneous coronary intervention; Within 24 hours from randomization
The periprocedural rate of onset and the proportion of patients who achieve effective\* P2Y12 platelet receptor inhibition defined by a Platelet Reactivity Index (PRI) value. \*PRI less than 50% as measured by the vasodilator-stimulated phosphoprotein phosphorylation flow cytometric assay
Primary Clinical Endpoint
时间窗: Within 30 days after randomization
The composite of all-cause death, myocardial infarction, or ischemic stroke expressed as a proportion of patients with any of these events.
次要结局
- Key secondary efficacy endpoint(Within 30 days and one year after randomization)
- Key secondary safety endpoint(Within 30 days and one year after randomization)
- Secondary net-clinical endpoint(Within 30 days and one year after randomization)
- Secondary efficacy endpoint(Within 30 days and one year after randomization)
- Secondary endpoint(From randomization to end of index event hospitalization, within 3 months after randomization)
- Other secondary outcome(Within 30 days after randomization)
- Other secondary efficacy endpoint(Within 30 days and one year after randomization)
- Other secondary endpoint(Initial phase of index event hospitalization, within 7 days after randomization)
- Secondary safety endpoint(Within 30 days after randomization)
- Secondary laboratory endpoint(1 hour after primary PCI)
- Secondary outcome(From randomization to the end of vasoactive pharmacotherapy / mechanical circulatory support, within 30 days after randomization)
研究者
Zuzana Motovska
Zuzana Motovska MD PHD
Faculty Hospital Kralovske Vinohrady