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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01572909 | Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events | PHASE2 | COMPLETED | 300 | — | — | Apr 1, 2012 | Feb 1, 2015 | Jun 11, 2020 | 30 | United States, Germany +2 |
Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
| Arm | Type | Description |
|---|---|---|
| Bendavia™ | ACTIVE_COMPARATOR | Bendavia™ administered intravenously at 0.05 mg/kg/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered intravenously at 60 mL/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel. |
| Name | Type | Description |
|---|---|---|
| Bendavia (MTP-131) | DRUG | 0.05 mg/kg/hr |
| Placebo | DRUG | Identically appearing placebo |
Inclusion Criteria: * Age ≥18 and \<85 years * The patient presents with first-time acute, anterior wall STEMI scheduled to undergo primary PCI and stenting. * The patient has symptoms of cardiac ischemia of ≥10 minutes. * The patient must demonstrate an anterior wall STEMI with \>0.1 millivolt (mV...