Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) has placed a hold on patient enrollment and dosing of drugs under investigation in the phase 3 REGULATE-PCI trial.
The trial is a comparison of the reversible thrombin inhibitor bivalirudin and the Revolixys Kit—a 2-component system consisting of pegnivacogin, an anticoagulant aptamer targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen—in patients undergoing percutaneous coronary intervention (PCI).
The company sponsoring the REGULATE-PCI trial, Regado Biosciences, had voluntarily halted enrollment prior to the FDA’s announcement. The FDA’s clinical hold formalizes its involvement in any decision to re-initiate enrollment and dosing in the trial in the future.
Regado stopped enrollment after its Data Safety Monitoring Board (DSMB) started an unplanned review of the study data. The board has said the review is focusing on serious adverse events and allergic reactions.
“[W]e remain blinded to REGULATE-PCI study data and are awaiting the outcome of the full safety and efficacy analysis, including an analysis of benefit/risk ratio, being performed by our DSMB,” said David J Mazzo, PhD, CEO of Regado.
“Any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based on the DSMB’s conclusions and would always be implemented in agreement with FDA.”
The REGULATE-PCI trial is a comparison of the Revolixys Kit (formerly known as REG-1) with bivalirudin (Angiomax) in patients undergoing PCI. The goal is to enroll 13,200 patients, and 3234 have been enrolled to date.
Eligible patients are those receiving PCI electively or for the treatment of unstable angina or non-ST elevated myocardial infarction.
Patients randomized to the Revolixys arm receive pegnivacogin at a dose of 1 mg/kg along with an 80% reversal dose of anivamersen. The timing of the remaining 20% is at the discretion of the treating physician.
The trial is powered to show superiority in efficacy and noninferiority in safety of the Revolixys Kit compared to bivalirudin. The study’s primary endpoint is a composite of death, nonfatal myocardial infarction, nonfatal stroke, and urgent target lesion revascularization through day 3 post-PCI.
For more details, visit clinicaltrials.gov.
