REGULATE-PCI Paused; DSMB Reviews Allergic Reactions, Safety

Shelley Wood

July 04, 2014

NEW YORK, NY — A large phase 3 randomized trial testing a new "controllable" antithrombotic has been paused by the data safety and monitoring board (DSMB) for an unplanned review, the trial sponsor announced this week.

REGULATE-PCI is designed as a 13 200-patient trial testing REG1 (Revolixys Kit, Regado Biosciences), a first-in-class, two-component product consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation factor IXa, and its complementary oligonucleotide active control agent, anivamersen. The trial is randomizing patients with ACS undergoing PCI to REG1 or bivalirudin (Angiomax, the Medicines Company) and has a primary composite end point of death, nonfatal MI, nonfatal stroke, and urgent target lesion revascularization through day 3.

In a press release issued Wednesday, Regado Biosciences says that 3234 patients have been enrolled in the trial so far and that the DSMB will be conducting "a full analysis of safety and treatment benefit/risk ratio," with a focus on serious adverse events related to allergic reactions. The company and trial leadership "have been and will remain blinded to study results during this period," the press release notes.

Speaking with heartwire , co–principal investigator Dr Roxana Mehran (Mount Sinai School of Medicine, New York, NY) pointed out that mild to moderate allergic reactions were seen in the phase 2 clinical study of REG1, called RADAR , as reported by heartwire .

She's hopeful that the review will be completed in a timely manner (the press release estimates eight weeks) and the trial can continue. More than half of patients already enrolled in REGULATE-PCI have been from US sites, she notes, which speaks to the interest in a reversible, controllable anticoagulant in a country that has seen a dwindling appetite for participation in large cardiovascular randomized controlled trials.

"This molecule is so exciting—imagine reversing your anticoagulation to 80% or even 100%? You can dial it up or down as you like."

The estimated study completion date is December 2013.

 

Mehran serves on the executive committee for REGULATE-PCI and is on the advisory board for Regado.

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