“We’re confident in the robust design of our clinical study and in our differentiated product design”
St. Jude Medical, Inc. has announced that it has met a stopping rule in its RESPECT clinical trial – triggered by reaching the protocol-required number of primary events in the trial, defined as stroke and all-cause mortality – and is closing patient enrollment. The company expects to present its findings during 2012.
A Patent Foramen Ovale (PFO) is one potential suspected cause of cryptogenic stroke. The foramen ovale is a flap or tunnel-shaped hole in the atrial septum, the wall that divides the upper two chambers of the heart, which forms during fetal development to allow blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. A PFO results if this opening does not completely close shortly after birth, and can allow a blood clot from one part of the body to travel through the flap and up to the brain, causing a stroke.
The RESPECT trial is a randomized, multi-center study investigating whether closure of the PFO using the St. Jude Medical AMPLATZER® PFO Occluder device, is safe and effective compared to current standard-of-care treatment in the prevention of a cryptogenic stroke. A cryptogenic stroke is one for which the origin or cause of stroke is unknown. The Amplatzer PFO Occluder Device was developed by AGA medical prior to its acquisition by St Jude Medical Inc in 2010. The product is CE marked but does not have FDA approval at the time of writing.
The RESPECT trial
The RESPECT trial is an event-driven, adaptive design that utilized defined outcome events to determine sample size via a series of stopping rules. This design allows the trial to continue until sufficient events have accumulated to be able to assess treatment effectiveness. The study design also means that by protocol, patients enrolled in the trial will continue to be followed until regulatory approval is granted by the U.S. Food and Drug Administration (FDA), thus providing substantial long-term follow-up on this patient population.
“With more than eight years of patient investigation and follow up that includes enrolling 980 patients and collecting more than 2,300 patient-years of data, we’re thrilled to announce that we have achieved a significant milestone in our RESPECT trial,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “We’re confident in the robust design of our clinical study and in our differentiated product design. We are currently focused on analyzing data from the trial and anticipate presenting results at a major medical meeting sometime in 2012.”
For more information on the clinical trial and the warning signs of stroke, visit www.respectstudy.com.
Source: St Jude Medical Inc