June 1, 2020
CeloNova Completes Enrollment in Trial of Cobra PzF NCS With 14-Day DAPT
June 1, 2020—CeloNova BioSciences, Inc. announced that it has successfully completed enrollment of the COBRA REDUCE randomized control trial.
According to CeloNova, the COBRA REDUCE trial is evaluating the safety and efficacy of the company's non–drug-eluting Cobra polyzene-F (PzF) nanocoated coronary stent (NCS) with 14-day dual antiplatelet therapy (DAPT) compared with FDA-approved drug-eluting stents (DESs) with 3 or 6 months DAPT in 996 patients at high bleeding risk (HBR) across 60 global sites. The trial is designed to assess superiority in terms of bleeding reduction (BARC ≥ 2) and noninferiority in the composite of death, myocardial infarction, stent thrombosis, and ischemic stroke.
All enrolled patients are on oral anticoagulation therapy (OAC), one of the major bleeding criteria per the Academic Research Consortium for High Bleeding Risk (ARC-HBR), which is known to increase bleeding and subsequent complications, noted the company. Many patients also share a second major or minor bleeding criteria, such as recent ischemic stroke, cancer, anemia, or severe or end-stage chronic kidney disease.
The trial is being coordinated by the ISAR Research Center in Munich, Germany.
“The outcome of the COBRA REDUCE trial represents a potentially game-changing approach to treating high bleeding risk patients,” commented the trial's coprincipal investigator Robert A. Byrne, MD, in CeloNova's announcement. Dr. Byrne, who is Professor of Cardiovascular Research at the RSCI University of Health Sciences in Dublin, Ireland, continued, “Physicians are still in need of a safe and effective treatment option for their most urgent or non-compliant patients who are at high bleeding risk. Data from this study evaluating COBRA PzF NCS with 14-day DAPT will provide valuable information on treatment options for this underserved patient population.”
Roxana Mehran, MD, stated in CeloNova's press release, “DAPT reduction strategies are of critical importance to the medical community. We anxiously await the results of the COBRA REDUCE trial as it will play an important role regarding this unmet need.” Dr. Mehran is Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine in New York, New York.
The company advised that the Cobra PzF NCS has been clinically proven to safely and effectively treat patients who may benefit from short, 1-month minimum DAPT. The device's PzF surface coating acts as a barrier between the device, intimal surface, and circulating elements in the blood.
The Cobra PzF NCS system is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. It is intended for use in patients eligible for percutaneous transluminal coronary angioplasty with a reference vessel diameter of 2.5 to 4 mm and lesion length of ≤ 24 mm.