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A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease (Hestia2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02482298
Recruitment Status : Completed
First Posted : June 26, 2015
Results First Posted : December 14, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to determine whether ticagrelor is effective in reducing the number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle cell disease

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Ticagrelor Drug: Placebo Phase 2

Detailed Description:

This is a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, study evaluating 2 doses of ticagrelor in 90 patients aged 18 to 30 years, with sickle cell disease (SCD). Patients will be randomised to double-blind double-dummy treatment period in a 1:1:1 ratio (30 to each treatment group) to receive ticagrelor 10 mg twice daily (bid), or ticagrelor 45 mg bid, or placebo bid to determine the frequency of days with pain using an electronic diary (eDiary) every day. Approximately 180 patients will be enrolled. Patient will be followed for safety assessment during and after 2 weeks of treatment completion.

During the 16 week treatment period, patients will complete a daily eDiary concerning daily pain intensity, pain location, use of analgesics and absence from school or work. At the end of the study patients will be asked to rate the change in their sickle cell pain compared to the start of treatment. Platelet aggregation will be measured and reported as P2Y12 reaction units (PRU) pre-dose and 2 hours post-dose at week 4 and week 5 after treatment start. Pharmacokinetic (PK) parameters will be measured at 2 hours post-dose at week 4, and pre-dose and at 2 hours post-dose at week 5. Biomarkers will be assessed pre-dose at week 4, week 5 and week 8. During the study, patients will be evaluated for adverse events (AEs) including bleeding and vaso-occlusive crisis (VOC).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomised, Double-blind, Double-dummy, Parallel-group, Multicenter, Phase IIb Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Number of Days With Pain in Young Adults With Sickle Cell Disease
Actual Study Start Date : July 9, 2015
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : November 16, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose A Drug: Ticagrelor
Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.
Experimental: Dose B Drug: Ticagrelor
Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.
Placebo Comparator: Placebo Drug: Placebo
10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary [ Time Frame: Baseline through Week 12 ]
    To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.


Secondary Outcome Measures :
  1. Average of the Daily Worst Pain Values Reported Via eDiary [ Time Frame: Baseline through Week 12 ]
    To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. Intensity of pain was recorded on an 11-point scale where 0 represented no pain and 10 represented the worst pain imaginable.

  2. Change in Proportion of Days With Analgesic Use Measured by an eDiary [ Time Frame: Baseline through Week 12 ]
    To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.


Other Outcome Measures:
  1. Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients) [ Time Frame: Baseline through Week 12 ]
    To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD

  2. Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events) [ Time Frame: Baseline through Week 12 ]
    To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0) by HPLC
  • If treated with hydroxyurea, the dose must have been stable for 3 months

Exclusion Criteria:

  • History of transient ischaemic attack or clinically overt cerebrovascular accident
  • Moderate or severe hepatic impairment
  • Treatment with chronic red blood cell transfusion therapy
  • Pre-dominate cause of pain is not sickle cell disease related
  • Chronic treatment with anticoagulants or antiplatelet drugs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482298


Locations
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United States, Florida
Research Site
Miami, Florida, United States, 33136
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29425
Egypt
Research Site
Alexandria, Egypt, 21131
Research Site
Cairo, Egypt, 11562
Research Site
Cairo, Egypt, 11566
France
Research Site
Bordeaux Cedex, France, 33076
Research Site
Strasbourg, France, 67091
Italy
Research Site
Verona, Italy, 37134
Kenya
Research Site
Kikuyu, Kenya, 00100
Research Site
Kisian, Kenya, 40100
Research Site
Nairobi, Kenya, 40100
Lebanon
Research Site
Beirut, Lebanon, 1107 2020
Research Site
Beirut, Lebanon, 113-6044
Turkey
Research Site
Adana, Turkey, 01130
Research Site
Mersin, Turkey, 33079
Research Site
Van, Turkey, 65080
United Kingdom
Research Site
Harrow, United Kingdom, HA1 3UJ
Research Site
London, United Kingdom, E1 1BB
Research Site
London, United Kingdom, E9 6SR
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Maria Ignacia -Berraondo, MD Quintiles, Inc.
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02482298    
Other Study ID Numbers: D5136C00008
First Posted: June 26, 2015    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 19, 2018
Last Verified: November 2018
Keywords provided by AstraZeneca:
Sickle cell disease
Young adults
Hestia2
Ticagrelor
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Ticagrelor
 Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs