Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board The RE-ALIGN trial was an open-label,…
Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients
December 12, 2012 by 2 Comments
Setback For Trial Studying Dabigatran After Mechanical Valve Surgery
October 23, 2012 by 2 Comments
Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…
New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
January 18, 2012 by 3 Comments
Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped. The news was announced by the trial sponsor, St. Jude Medical. FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal…
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