Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction (DAPT-SHOCK-AMI)
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|ClinicalTrials.gov Identifier: NCT03551964|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction Cardiogenic Shock||Drug: Cangrelor Drug: Ticagrelor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Cangrelor therapy
Initiation of iv Cangrelor immediately upon arrival of the patient to the cardiac catheterization laboratory and after randomization into the study.
Cangrelor: IV bolus 30 μg/kg (application < 1 minute), immediately followed by continuous infusion in the dose of 4 μg/kg/min. To accelerate the initiation of therapy, tables containing calculations of the bolus dose in ml and the speed of infusion therapy for individual weights will be prepared.
Other Name: intravenous P2Y12 inhibitor
Active Comparator: Ticagrelor therapy
Initial dose Ticagrelor immediately upon arrival of the patient to the cardiac catheterization laboratory and after randomization into the study. In patients with a disorder of consciousness, initial dose of Ticagrelor will be administered immediately after nasogastric tube insertion.
Initial dose crushed Ticagrelor 180 mg. Maintenance dose Ticagrelor 90 mg twice daily for 12 months.
Other Name: oral P2Y12 inhibitor
- Clinical endpoint [ Time Frame: Within 30 days after randomization ]Combined endpoint defined as Death/Myocardial infarction/Stroke
- Laboratory endpoint [ Time Frame: Periprocedural (periPCI) period ]Early achievement of efficient inhibition of ADP-induced platelet aggregation. Efficient inhibition is defined by the Platelet Reactivity Index (determined based on the VASP protein phosphorylation) < 50%.
- Key secondary net-clinical endpoint [ Time Frame: Within 30 days after randomization ]Death/Myocardial infarction/Urgent revascularisation of the infarct-related artery /Stroke/Major bleeding BARC ≥ 3
- Key safety endpoint [ Time Frame: Within 30 days after randomization ]Incidence of bleeding according to the BARC definition
- Other secondary endpoint [ Time Frame: Within 30 days and one year after randomization ]Individual components of the primary clinical endpoint
- Other secondary endpoint [ Time Frame: Within 30 days and one year after randomization. ]Death from cardiovascular causes
- Secondary endpoint [ Time Frame: Within 30 days after randomization ]Definite stent thrombosis
- Secondary endpoint [ Time Frame: Within 30 days after randomization ]Duration of vasoactive pharmacotherapy and/or mechanical circulatory support (norepinephrine/epinephrine/dopamine in the dose > 5 μg/kg/min/IABP/ECMO),
- Secondary endpoint [ Time Frame: Index event Hospitalization ]Duration of hospitalisation
- Secondary endpoint [ Time Frame: Within 30 days after randomization ]Delaying the surgery due to bleeding
- Cost analysis [ Time Frame: Within 30 day after randomization ]Cost-effectiveness analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551964
|Contact: Zuzana Motovska, MD. PhD.||+email@example.com|
|Principal Investigator:||Zuzana Motovska, MD. PhD.||University Hospital Kralovske Vinohrady, Prague, Czech Republic|