Conditions

Sickle Cell Anemia

Keywords

Sickle Cell DiseaseSickle Cell AnemiaAdult

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration
A hemorrhagic event requiring medical intervention. Medical intervention was defined as any medical attention resulting in therapy or further investigation during the 30-day treatment duration.
Baseline through 30 days

Secondary Outcomes (6)

Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration
Baseline through 30 days
Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration
Baseline through 30 days
Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration
Baseline through 30 days
Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days
30 days
Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration
Baseline through 30 days
+1 more secondary outcomes

Study Arms (3)

7.5 mg Prasugrel

EXPERIMENTAL

Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.

Drug: Prasugrel

Placebo

PLACEBO COMPARATOR

Drug: Placebo

5 mg Prasugrel

EXPERIMENTAL

Drug: Prasugrel

Interventions

PrasugrelDRUG

Administered orally, once daily for 30 days.

Also known as: Efient, Effient, LY640315, CS747

5 mg Prasugrel7.5 mg Prasugrel

PlaceboDRUG

Administered orally, once daily for 30 days.

Placebo

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Adults with Sickle Cell Disease (SCD).
Are greater than or equal to 50 kilograms (kg) at time of screening.
Are not currently being treated with an investigational drug (use of hydroxyurea, which is not an investigational drug, is permitted under this protocol if the patient has been on a stable dose for at least 30 days prior to randomization and has no signs of hematological toxicity at screening.
Agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.

You may not qualify if:

Acute painful crisis (requiring medical attention) within 30 days prior to screening.
Have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 30 days).
Severe hepatic dysfunction (cirrhosis, portal hypertension, or aspartate aminotransferase (AST) greater than or equal to 3x upper limit of normal \[ULN\]).
Renal dysfunction requiring chronic dialysis.
Contraindication for antiplatelet therapy.
History of intolerance or allergy to approved thienopyridines.
Have signs or symptoms of an infection.
Hypertension (systolic blood pressure \>180 millimeters of mercury (mm Hg) or diastolic blood pressure \>110 mm Hg) at the time of screening or randomization.
Hematocrit \<18%.
Any history of bleeding diathesis, bleeding requiring in-hospital treatment, or papillary necrosis.
Active internal bleeding.
History of spontaneous gastrointestinal (GI) bleeding requiring in-hospital treatment.
Gross hematuria. Microhematuria, common in SCD patients, is not a contraindication.
Platelet count \<100,000 per cubic millimeter.
Any history of intraocular hemorrhage.
+6 more criteria

Contact the study team to confirm eligibility.