Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction - DAPT-SHOCK-AMI study (PRAGUE-23)

niversity Hospital Kralovske Vinohrady0 个研究点目标入组 550 人开始时间: 2022年2月18日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•1. Age over 18 years
•2. Acute myocardial infarction according to the definition of ESC/ACC/AHA, indicated for emergency percutaneous coronary intervention (primary PCI strategy)
•3. Cardiogenic shock present upon admission due to the AMI (= 2 of the criteria below are satisfied)
•a) sBP < 90 mmHg with the absence of hypovolemia
•b) Need of vasopressor and/or inotropic therapy
•c) Presence of the signs of the organ hypoperfusion - cyanosis, cold acra, disorder of consciousness, congestive heart failure
•4. Informed consent form signed
•5. Women of childbearing potential should be protected from pregnancy and use a highly effective method of contraception throughout the study (relevant for long-term use of ticagrelor). Highly effective methods of contraception include: combined hormonal contraception (oral, vaginal or transdermal form), gestagen hormonal contraception associated with ovulation inhibition (oral or injectable form), non-hormonal intrauterine device, intrauterine hormone-releasing device, bilateral tubal occlusion, sexual abstinence or complete withdrawal – as long as it is consistent with the patient´s lifestyle. Suitable method of contraception in this case should be consulted with a gynecologist.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 275
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 275

•1. Contraindications of antiplatelet therapy with ticagrelor/cangrelor
•o Recent (< 6 months) major bleeding
•o Recent (< 1 month) major surgery/injury
•o History of intracranial bleeding
•o History of stroke/TIA
•o Known intolerance to ticagrelor/cangrelor and hypersensitivity to any of the excipients of the investigational medicinal products and to excipients of the placebos
•o Severe impairment of hepatic function
•o Concomitant administration of strong CYP3A4 inhibitors (for example, ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
•2. Administration of a loading dose of an oral P2Y12 inhibitor prior to admission (clopidogrel = 300 mg, ticagrelor 180 mg, prasugrel 60 mg)
•3. Need of concomitant chronic anticoagulation therapy due to indications such as atrial fibrillation, artificial valve, thromboembolic disease, etc.

发起方

niversity Hospital Kralovske Vinohrady