LEADERS-FREE is a randomized double-blinded trial which was designed to assess the combination of a short course (1 month) of DAPT with either the BioFreedom DCS (drug-coated stent) or the Gazelle BMS in patients with at least one of several criteria for an increased bleeding risk: advanced age, oral anticoagulant treatment, recent bleeding, anaemia, and co-morbid conditions such as chronic renal failure or cancer.
Sponsor
Study objectives
The trial has three central features:
1. A focus on a “forgotten” patient subset
2. A double-blinded design (neither the patient nor the operator will know whether a BioFreedom DCS or a BMS control is implanted)
3. The use of two separate co-primary endpoints at 1 year: (BioFreedom vs. BMS) non-inferiority for safety (death, MI and urgent TLR) and superiority for efficacy (any clinically driven TLR)
The recruitment was finalized in May 2014 with the inclusion of 2466 patients in 68 European, Asian, Australian and Canadian sites.
Primary endpoints
The primary study endpoints, which were reached in May 2015, will be presented by Philip Urban in the Late Breaking Trials session at TCT 2015 in San Francisco.
CERC Services
- Monitoring activities
- CEC and DSMB activities
- Core Laboratory
- Project management
Countries
20 : France (FR), Germany (DE), Spain (ES), United Kingdom (UK), Switzerland (CH), Singapore (SG), Denmark (DK), Hong Kong (HK), Italy (IT), Malaysia (MY), Thailand (TH), Latvia (LV), Norway (NO), Belgium (BE), Netherlands (NL), Canada (CA), Australia (AU), Ireland (IE), Israel (IL), Austria (AT).
Number of investigational sites
68 European, Asian, Australian and Canadian sites
Number of patients
2466
