NCT05350592Active, not recruitingPhase 2
Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock
Low-dose Dobutamine Infusion and Single-dose Tocilizumab in Acute Myocardial Infarction Patients With High Risk of Cardiogenic Shock Development - a 2x2 Multifactorial, Double-blinded, Randomized, Placebo Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
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 intervention (PCI) to patients with acute myocardial infarction (AMI) presenting \< 24 hours from onset of chest pain and an intermediate to high risk of cardiogenic shock (CS) by assessment with the ORBI risk score (≥10 - not in overt shock at hospital admission). Plasma concentrations of pro-B-type natriuretic peptide (proBNP) as a proxy for development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary endpoint analysis. Effects on clinical parameters, mortality, morbidity as well as specific indicators of inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively. The rationale behind the current study is that inflammatory and neurohormonal responses are associated with subclinical hemodynamic instability in patients with AMI with high risk of CS have worse outcomes. The potentially unstable condition may be targeted pharmacologically as an add-on to existing therapy. This is investigated in patients at elevated risk of CS by sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as determining effects on patient outcomes and infarct size.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 8 Mar 2022
- Start date
- 13 Mar 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Coronary artery disease
- NCT number
- NCT05350592
- EudraCT number
- 2021-002028-19
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 13 Mar 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis)
- Immune deficiency/treatment with immunosuppressants
Other illness
- Comatose after cardiac arrest
- Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score
- Tocilizumab allergy
- Known liver disease/dysfunction
- Ongoing uncontrollable infection
- Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
Lab values
- 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
- Unwilling to give informed consent to study participation
- Unable to give consent due to language barrier
- Referral for acute coronary artery bypass grafting (CABG) (\< 24 hours) after the CAG
- Pregnant- or breastfeeding women
Who the study is looking for
- Acute myocardial infarction
- Revascularization with PCI
- Presentation within 24 hours of chest pain
- ORBI risk score ≥ 10
- Age ≥ 18
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet (Copenhagen University Hospital) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.