Abstract | BACKGROUND: 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 Sβ(0) thalassemia [HbSβ(0)]). 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.
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Authors | Carolyn C Hoppe, Lori Styles, Lori E Heath, Chunmei Zhou, Joseph A Jakubowski, Kenneth J Winters, Patricia B Brown, David C Rees, Matthew M Heeney |
Journal | Pediatric blood & cancer
(Pediatr Blood Cancer)
Vol. 63
Issue 2
Pg. 299-305
(Feb 2016)
ISSN: 1545-5017 [Electronic] United States |
PMID | 26402148
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 Wiley Periodicals, Inc. |
Chemical References |
- Platelet Aggregation Inhibitors
- Prasugrel Hydrochloride
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Topics |
- Adolescent
- Anemia, Sickle Cell
(complications, drug therapy)
- Child
- Child, Preschool
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Male
- Pain
(etiology)
- Platelet Aggregation Inhibitors
(therapeutic use)
- Prasugrel Hydrochloride
(therapeutic use)
- Research Design
- Vascular Diseases
(prevention & control)
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