2013
A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease
Wun T, Soulieres D, Frelinger A, Krishnamurti L, Novelli E, Kutlar A, Ataga K, Knupp C, McMahon L, Strouse J, Zhou C, Heath L, Nwachuku C, Jakubowski J, Riesmeyer J, Winters K. A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease. Journal Of Hematology & Oncology 2013, 6: 17. PMID: 23414938, PMCID: PMC3585853, DOI: 10.1186/1756-8722-6-17.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAnemia, Sickle CellBiomarkers, TumorCell Adhesion MoleculesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMicrofilament ProteinsMiddle AgedPainPhosphoproteinsPiperazinesPlatelet ActivationPlatelet Aggregation InhibitorsPrasugrel HydrochloridePrognosisPurinergic P2Y Receptor AntagonistsThiophenesYoung AdultConceptsSickle cell diseaseHemorrhagic eventsAdult patientsAntiplatelet agentsSCD patientsCell diseaseP-selectinMedical interventionsMulticenter phase 2 studyPlatelet surface P-selectinMethodsThe primary endpointPlatelet activation biomarkersSafety of prasugrelSerious hemorrhagic eventsPlacebo-controlled studyPhase 2 studyVivo platelet activationSoluble P-selectinSurface P-selectinThienopyridine antiplatelet agentPain ratePrasugrel armPrimary endpointActivation biomarkersStudy arms
2011
A Randomized, Double-Blind, Adaptive Phase 2 Multi-Center Study of Prasugrel Compared to Placebo in Adults with Sickle Cell Disease
Wun T, Soulieres D, Krishnamurti L, Kutlar A, Ataga K, Zhou C, Heath L, Nwachuku C, Jakubowski J, Winters K, Riesmeyer J. A Randomized, Double-Blind, Adaptive Phase 2 Multi-Center Study of Prasugrel Compared to Placebo in Adults with Sickle Cell Disease. Blood 2011, 118: 847. DOI: 10.1182/blood.v118.21.847.847.Peer-Reviewed Original ResearchSickle cell diseasePrasugrel armHemorrhagic eventsCell diseaseMedical attentionPain rateAdult patientsPlacebo armPlatelet inhibitionAntiplatelet agentsPharmacodynamic effectsEli LillyP2Y12 ADP receptor antagonistsHemorrhagic adverse eventsInsufficient platelet inhibitionP2Y12 reactivity unitsPrasugrel-treated patientsSerious hemorrhagic eventsADP receptor antagonistsPlatelet reactivity indexAcute coronary syndromeBaseline pain intensityPhase 2 studyPhase 3 studySeverity of pain