Senior - V 13.0, 14th January 2014
Research type
Research Study
Full title
Short duration of dual antiplatElet therapy with SyNergy® II everolimus eluting stent in patients Older than 75 years undergoing percutaneous coronary Revascularization.The SENIOR trial.
IRAS ID
152820
Contact name
Adam Julian de Belder
Contact email
Sponsor organisation
Ceric Sàrl
Clinicaltrials.gov Identifier
Research summary
Coronary artery disease is a prevalent disease in patients = 75 years with or without other risk factors. Aging of the population leads to frequent hospitalizations and significant medical and economic burden. However, there is currently no clear recommendation for how to treat specifically patients above 75 years suffering coronary artery disease (CAD).
SENIOR trial is designed to establish efficacy and safety of the Synergy® II everolimus eluting stent with abluminal biodegradable polymer (EESabp) associated with a short dual antiplatelet therapy (DAPT) in patients =75 years old, suffering from stable angina, silent ischemia or acute coronary syndromes related to significant coronary artery disease and requiring percutaneous coronary intervention.
SENIOR trial aims to demonstrate that EESabp in patients =75 years old is associated with a lower rate of the composite of all-cause mortality, myocardial infarction, stroke or ischemia driven target lesion revascularization (efficacy) and a similar risk of major bleeding (safety) than bare metal stent at an anticipated median follow-duration of one year.
Different stents will be used, Synergy® II (EESabp) and Omega® or Rebel® as comparators (BMS stents). After implantation, an antiplatelet regimen will be administered. DAPT will be similar after Synergy® II and BMS implantation and will be composed of aspirin and a ADP P2Y12 receptors inhibitors. DAPT duration will be one month after percutaneous coronary intervention for stable angina and silent ischemia or six months after percutaneous coronary intervention for acute coronary syndrome, irrespective of the type of stent (Synergy® II or BMS).
To be eligible the patient must meet all inclusion criteria and any exclusion criteria.
SENIOR trial will include around 1200 patients, in approximately 40 sites, in 7 European countries and Switzerland.
SENIOR trial will last around 3 years. Patient recruitment will last 1 year and patient follow-up duration is 2 years.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
14/YH/1069
Date of REC Opinion
26 Jul 2014
REC opinion
Unfavourable Opinion