Prasugrel Versus Placebo in Adult Sickle Cell Disease
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Intervention: Prasugrel; Placebo
Intervention description: Administered orally, once daily for 30 days.; Administered orally, once daily for 30 days.
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Sickle Cell Anemia; Adult

Summary:

      The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle
      cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring
      medical intervention compared to placebo for 30 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

          -  Prior history of transient ischemic attack (TIA), ischemic stroke, hemorrhagic stroke,
             or other intracranial hemorrhage.

          -  Known history of intracranial neoplasm, arteriovenous malformation, or aneurysm.

          -  Have clinical findings, in the judgment of the investigator, associated with an
             increased risk of bleeding.

          -  Have an international normalized ratio (INR) of greater than 1.5 at screening.

          -  Have had recent surgery (within 30 days prior to screening) or are scheduled to
             undergo surgery within the next 60 days.

          -  History of menorrhagia requiring medical intervention.