Phase 2
N=62
Prasugrel Versus Placebo in Adult Sickle Cell Disease
Sickle Cell Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01167023 ↗Enrolled (actual)
62
Serious AEs
20.0%
Results posted
May 2012
Primary outcome: Primary: Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration — 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prasugrel (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration |
0; 0 | — |
| SECONDARY Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration |
5.3; 19.5 | — |
| SECONDARY Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration |
63.57; 39.04 | 0.304 |
| SECONDARY Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration |
36.8; 22.5 | — |
| SECONDARY Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days |
74.843; 50.792 | <0.001 sig |
| SECONDARY Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration |
2.72; 1.56 | 0.244 |
| SECONDARY P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days |
336.8; 208.5 | <0.001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01167023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.