Design of the DOVE (Determining Effects of Platelet Inhibition on Vaso-Occlusive Events) trial: A global Phase 3 double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of prasugrel in pediatric patients with sickle cell anemia utilizing a dose titration strategy
| Autor: | Patricia B. Brown, Carolyn Hoppe, Kenneth J. Winters, Matthew M. Heeney, Lori Styles, Chunmei Zhou, Joseph A. Jakubowski, David C. Rees, Lori E. Heath |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Acute coronary syndrome Prasugrel Thienopyridine Adolescent Pain Anemia Sickle Cell 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Platelet activation Vascular Diseases Child Prasugrel Hydrochloride Dose-Response Relationship Drug business.industry Hematology medicine.disease Acute chest syndrome Oncology Research Design 030220 oncology & carcinogenesis Anesthesia Child Preschool Pediatrics Perinatology and Child Health Platelet aggregation inhibitor Female business Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | Pediatric bloodcancer. 63(2) |
| ISSN: | 1545-5017 |
| Popis: | Background Sickle cell disease (SCD) is an inherited blood disorder characterized by painful vaso-occlusive crises (VOC) with limited treatment options, particularly for children. Emerging knowledge of the pathophysiology of SCD suggests antiplatelet therapies may hold promise for treatment of VOC. Multiple small studies have evaluated antiplatelet agents on the frequency of VOC with varying results, but there has not been an adequately powered study to definitively determine the effect of antiplatelet agents on VOC. Prasugrel, a third-generation thienopyridine that irreversibly inhibits platelet activation and aggregation, is approved in adults with acute coronary syndrome managed with percutaneous coronary intervention. Procedure Determining Effects of Platelet Inhibition on Vaso-Occlusive Events (DOVE) is a double-blind, randomized study with planned enrollment of >220 children from 14 countries across the Americas, Europe, Asia, and Africa, designed to test the hypothesis that prasugrel reduces the rate of VOC in children with sickle cell anemia (SCA) (homozygous hemoglobin S [HbSS] and hemoglobin Sβ0 thalassemia [HbSβ0]). Secondary study endpoints include reductions in rate and intensity of vaso-occlusive pain as recorded in daily electronic diaries. Safety assessments include incidence of hemorrhagic events requiring medical intervention and treatment-emergent adverse events. DOVE incorporates a dose-titration strategy to reduce potential bleeding risks inherent with antiplatelet therapy while maintaining blinded treatment assignment. Conclusions DOVE presents a unique opportunity to determine whether antiplatelet therapy reduces frequency of patient-reported VOC and daily vaso-occlusive pain in a global study of children with SCA. Pediatr Blood Cancer © 2015 Wiley Periodicals, Inc. |
| Databáze: | OpenAIRE |
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