Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05350592 | Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock | PHASE2 | ACTIVE NOT_RECRUITING | 100 | — | — | Mar 13, 2022 | Sep 30, 2025 | Jul 17, 2025 | 1 | Denmark |
ProBNP plasma concentration being assessed at multiple time points (including the primary endpoint) will be analyzed by application of a linear mixed model of covariance. As the biomarker will be measured prior to initiation of the study drug, the models will be baseline corrected (i.e., constrained linear mixed models, CLMM). The main result of these analyses will be the treatment-by-time interaction as a marker of whether the proBNP levels change differently over time in the treatment versus the placebo arm.
| Arm | Type | Description |
|---|---|---|
| Tocilizumab + Dobutamine | ACTIVE_COMPARATOR | Tocilizumab IV 280 mg (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) |
| Tocilizumab + Placebo | ACTIVE_COMPARATOR | Tocilizumab IV 280 mg (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) |
| Placebo + Dobutamine | ACTIVE_COMPARATOR | NaCl 0,9% IV (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) |
| Placebo + Placebo | PLACEBO_COMPARATOR | NaCl 0,9% IV (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) |
| Name | Type | Description |
|---|---|---|
| Tocilizumab | DRUG | Single bolus |
| Dobutamine | DRUG | Continous weight-adjusted infusion |
| NaCl 0.9% | DRUG | Placebo comparator and diluent |
Inclusion Criteria: * Acute myocardial infarction * Revascularization with PCI * Presentation within 24 hours of chest pain * ORBI risk score ≥ 10 * Age ≥ 18 Exclusion Criteria: * Unwilling to give informed consent to study participation * Unable to give consent due to language barrier * Comatose...