A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease

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Wun, Ted; Soulieres, Denis; Frelinger, Andrew L; Krishnamurti, Lakshmanan; Novelli, Enrico M; Kutlar, Abdullah; Ataga, Kenneth I; Knupp, Charles L; McMahon, Lillian E; Strouse, John J; Zhou, Chunmei; Heath, Lori E; Nwachuku, Chuke E; Jakubowski, Joseph A; Riesmeyer, Jeffrey S; Winters, Kenneth J
Abstract
Background Platelet activation has been implicated in the pathogenesis of sickle cell disease (SCD) suggesting antiplatelet agents may be therapeutic. To evaluate the safety of prasugrel, a thienopyridine antiplatelet agent, in adult patients with SCD, we conducted a double-blind, randomized, placebo-controlled study. Methods The primary endpoint, safety, was measured by hemorrhagic events requiring medical intervention. Patients were randomized to prasugrel 5 mg daily (n = 41) or placebo (n = 21) for 30 days. Platelet function by VerifyNow® P2Y12 and vasodilator-stimulated phosphoprotein assays at days 10 and 30 were significantly inhibited in prasugrel- compared with placebo-treated SCD patients. Results There were no hemorrhagic events requiring medical intervention in either study arm. Mean pain rate (percentage of days with pain) and intensity in the prasugrel arm were decreased compared with placebo. However, these decreases did not reach statistical significance. Platelet surface P-selectin and plasma soluble P-selectin, biomarkers of in vivo platelet activation, were significantly reduced in SCD patients receiving prasugrel compared with placebo. In sum, prasugrel was well tolerated and not associated with serious hemorrhagic events. Conclusions Despite the small size and short duration of this study, there was a decrease in platelet activation biomarkers and a trend toward decreased pain.
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http://hdl.handle.net/10342/8278
Subject
Prasugrel, Sickle cell disease, Thienopyridine, Platelet function
Date
2013-02
Citation:
APA:
Wun, Ted, & Soulieres, Denis, & Frelinger, Andrew L, & Krishnamurti, Lakshmanan, & Novelli, Enrico M, & Kutlar, Abdullah, & Ataga, Kenneth I, & Knupp, Charles L, & McMahon, Lillian E, & Strouse, John J, & Zhou, Chunmei, & Heath, Lori E, & Nwachuku, Chuke E, & Jakubowski, Joseph A, & Riesmeyer, Jeffrey S, & Winters, Kenneth J. (February 2013). A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease. , (), - . Retrieved from http://hdl.handle.net/10342/8278

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MLA:
Wun, Ted, and Soulieres, Denis, and Frelinger, Andrew L, and Krishnamurti, Lakshmanan, and Novelli, Enrico M, and Kutlar, Abdullah, and Ataga, Kenneth I, and Knupp, Charles L, and McMahon, Lillian E, and Strouse, John J, and Zhou, Chunmei, and Heath, Lori E, and Nwachuku, Chuke E, and Jakubowski, Joseph A, and Riesmeyer, Jeffrey S, and Winters, Kenneth J. "A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease". . . (), February 2013. September 27, 2023. http://hdl.handle.net/10342/8278.
Chicago:
Wun, Ted and Soulieres, Denis and Frelinger, Andrew L and Krishnamurti, Lakshmanan and Novelli, Enrico M and Kutlar, Abdullah and Ataga, Kenneth I and Knupp, Charles L and McMahon, Lillian E and Strouse, John J and Zhou, Chunmei and Heath, Lori E and Nwachuku, Chuke E and Jakubowski, Joseph A and Riesmeyer, Jeffrey S and Winters, Kenneth J, "A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease," , no. (February 2013), http://hdl.handle.net/10342/8278 (accessed September 27, 2023).
AMA:
Wun, Ted, Soulieres, Denis, Frelinger, Andrew L, Krishnamurti, Lakshmanan, Novelli, Enrico M, Kutlar, Abdullah, Ataga, Kenneth I, Knupp, Charles L, McMahon, Lillian E, Strouse, John J, Zhou, Chunmei, Heath, Lori E, Nwachuku, Chuke E, Jakubowski, Joseph A, Riesmeyer, Jeffrey S, Winters, Kenneth J. A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease. . February 2013; (): . http://hdl.handle.net/10342/8278. Accessed September 27, 2023.
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