Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction (NCT03551964) | Clinical Trial Compass
CompletedPhase 4
Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction
Czechia605 participantsStarted 2018-08-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕
What they're measuring
1
Primary Laboratory endpoint
Timeframe: At the end of primary percutaneous coronary intervention; Within 24 hours from randomization
. Contraindications of antiplatelet therapy with ticagrelor/cangrelor
✕. 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.