First patient enrolled in ANGIODAPT Trial, an RCT of abbreviated DAPT post-stent implantation with Angiolite DES.
iVascular has announced the initiation of its first randomized trial of an abbreviated dual antiplatelet therapy (DAPT) regimen after drug-eluting stent angiolite implantation.
The first patient was enrolled by the team of the Principal Investigator of the trial, Dr. Manel Sabaté (Head of the Interventional Cardiology Department at the Hospital Clinic Barcelona, Spain) launching the global investigation.
ANGIODAPT trial is iVascular’s 2×2 factorial, all-comer, multicenter, randomized controlled trial set up to evaluate the ischemic and bleeding outcomes after iVascular angiolite stent implantation and an abbreviated DAPT (1 month). A total of 2.312 patients with coronary artery disease, who require percutaneous coronary intervention and DAPT, will be included across 40 sites located in Spain, Belgium and France.
Patients will be randomized firstly to one of the stents family (angiolite versus Xience) and secondly assigned to one of the treatment options (abbreviated DAPT versus standard of care DAPT) and will be followed up 1, 6 and 12-months after the intervention and annually for 5 years.
The trial’s two co-primary endpoints are to determine the rate of target lesion failure (TLF) at 1-year between angiolite and Xience stent family (tested for non-inferiority) in both the ‘abbreviated DAPT’ and the ‘standard-of-care DAPT’ regimen groups. The co-primary endpoint is to determine the rate of clinically relevant bleeding events at 1 year between ‘abbreviated DAPT’ and the ‘standard-of-care DAPT’ (tested for superiority of the ‘abbreviated-DAPT arm’).
The main secondary endpoint is to determine the rate of ischemic events between both therapies (tested for non-inferiority). Moreover, other exploratory outcomes as rate of patient-oriented composite endpoint, myocardial infarction, target lesion and vessel revascularization, stent thrombosis, clinical device and procedural success, bleeding events, net adverse clinical endpoints, the major adverse cardiac and cerebral events and transfusion rates will be assessed.
Throughout the trial, the steering committee composed of international well-known doctors (Dr. Manel Sabaté, Dr. Rodés, Dr. Brugaletta, Dr. Ortega, Dr. Dewilde and Dr. Garot) along with the clinical events committee (CEC) and the data safety monitoring board (DSMB) will ensure the safety of the patients and the scientific integrity of the study.
Dr. Manel Sabaté stated “The enrollment of the first patient in the angioDAPT trial is an important milestone to get robust evidence on DAPT regimen in CAD patients who have received angiolite stent. I am sure that the 2.300 patients will be enrolled on time thanks to the cooperation of the participant sites and their teams.”