Regado BioSciences announced the permanent hold of the Phase 3 REGULATE-PCI trial in August 2014, which compared Revolixys Kit (pegnivacogin/anivamersen; REG1 Anticoagulation System) to bivalirudin in patients undergoing percutaneous coronary intervention (PCI).
The trial was halted based on a recommendation from the trial’s Data and Safety Monitoring Board (DSMB) following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin. Severe allergic reactions were documented in 10 out of 1,605 patients in the REG1 arm, of which one was fatal and the others were anaphylactic reactions. Only one patient in the bivalirudin group had a serious allergic event. The allergic reactions were observed in both the Phase 2 and Phase 3 studies.
REGULATE-PCI is a randomized, open-label, multi-center, active-controlled, parallel group study designed to determine the efficacy and safety of the REG1 Anticoagulation System compared to bivalirudin in patients undergoing PCI as a treatment for coronary artery disease. The primary efficacy endpoint was the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.
No differences were found between patients receiving REG1 and bivalirudin for the primary efficacy endpoint (6.7% in the REG1 arm and 6.4% in the bivalirudin arm).Efficacy was still comparable at 30 days. Patients receiving REG1 had a 0.4% rate of severe or fatal bleeding compared to 0.1% in the bivalirudin arm. Moderate to severe bleeding was significantly higher in the REG1 group compared to bivalirudin.
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