Status:
ACTIVE_NOT_RECRUITING
Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Novo Nordisk A/S
Simon Spies Fonden
Conditions:
Acute Myocardial Infarction
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary interve...
Detailed Description
The planned study is an investigator-initiated, randomized, double blinded clinical trial. Consecutive patients at Copenhagen University Hospital, Rigshospitalet admitted with AMI \< 24 hours from ch...
Eligibility Criteria
Inclusion
- Acute myocardial infarction
- Revascularization with PCI
- Presentation within 24 hours of chest pain
- ORBI risk score ≥ 10
- Age ≥ 18
Exclusion
- Unwilling to give informed consent to study participation
- Unable to give consent due to language barrier
- Comatose after cardiac arrest
- Cardiogenic shock with systolic blood pressure \< 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate \> 2,5 (2,0) mmol/L developed before leaving the cath. lab.
- Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score
- Referral for acute coronary artery bypass grafting (CABG) (\< 24 hours) after the CAG
- Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis)
- Tocilizumab allergy
- Pregnant- or breastfeeding women
- Known liver disease/dysfunction
- Ongoing uncontrollable infection
- Immune deficiency/treatment with immunosuppressants
- Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
Key Trial Info
Start Date :
March 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05350592
Start Date
March 13 2022
End Date
September 30 2025
Last Update
July 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, 2100