Study participants sought to test reversal agent for new generation of blood thinners
Participants are currently being recruited for a clinical trial designed to test antidotes to reverse the effects of a new generation of blood thinners in the event of internal bleeding events. The study is sponsored by Gines Escolar and Spain’s Ministry of Health and is being conducted in hospitals throughout the country.
The study focuses on two new anticoagulants – Xarelto (rivaroxaban) and Pradaxa (dabigatran). Both medications are used to prevent strokes in patients with a common heart condition known as atrial fibrillation. Pradaxa is approved for use in both the United States and Europe. Xarelto is approved in Europe, and is currently under review in the United States.
Both blood thinners are in a class of drugs known as direct thrombin inhibitors, and are considered some of the first alternatives to warfarin. Warfarin has been on the market for more than 50 years, but it has numerous interactions and requires frequent monitoring. All blood thinners carry a risk for bleeding. Unlike warfarin, there is no specific way to reverse the anticoagulant effect of Xarelto or Pradaxa in the event of a major bleed.
The studies will be performed using blood samples from healthy individuals subjected to treatments with the new anticoagulants at doses of proven efficacy and safety. Blood samples from the participants will be spiked “in vitro” with specific concentrations of the coagulation factors.
In order to participate in the study, patients must be healthy adults between 21 and 60 year of age, and must be free of hepatic or kidney disease; have no previous history of hemorrhagic or thrombotic disease; not be pregnant or breast feeding; must not be taking medications that affect hemostasis; must not be using medications of herbal treatments that could interfere with the pharmacokinetics or pharmacodynamics of the study drug; not be involved in risky sports during the study period; and not have donated blood in the previous three months.
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