Prasugrel Versus Placebo in Adult Sickle Cell Disease
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Anemia
Intervention: Prasugrel (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: A Double-Blind, Randomized, Multicenter Study of Prasugrel Compared to Placebo in Adult Patients With Sickle Cell Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration
Secondary outcome: Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment DurationPercentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Birmingham, Alabama 35205, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Little Rock, Arkansas 72211, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sacramento, California 95817, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Daytona Beach, Florida 32117, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Augusta, Georgia 30912, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana 46260, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Baltimore, Maryland 21205, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Boston, Massachusetts 02118, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jackson, Mississippi 39216, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chapel Hill, North Carolina 27599, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Greenville, North Carolina 27834, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jenkintown, Pennsylvania 19046, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pittsburgh, Pennsylvania 15224, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Houston, Texas 77002, United States
Additional Information
Starting date: July 2010
Last updated: April 9, 2012
|