Prasugrel Versus Placebo in Adult Sickle Cell Disease

Lilly

Status and phase: Completed; Phase 2

Conditions: Sickle Cell Anemia

Treatments: Drug: Prasugrel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167023

13806

H7T-MC-TAEK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 3 patient groups, including a placebo group

7.5 mg Prasugrel

Experimental group

Description:

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.

Treatment:

Drug: Prasugrel

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

5 mg Prasugrel

Experimental group

Treatment:

Drug: Prasugrel