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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 Duration

Percentage 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

Page last updated: August 20, 2015

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