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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02482298
First Posted: June 26, 2015
Last Update Posted: November 15, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Sickle Cell Disease Drug: Ticagrelor Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of days with pain due to Sickle Cell Disease [ Time Frame: 16 weeks ]
    Pain assessment will be captured daily from enrolment to end of treatment using an eDiary.


Secondary Outcome Measures:
  • Intensity of pain due to Sickle Cell Disease [ Time Frame: 16 weeks ]
    Pain intensity will be captured daily from enrolment to end of treatment using an eDiary. The numerical rating scale (NRS) asks the patient to rate the intensity of his/her worst pain and average pain during the past 24 hours and pain right now, using an 11-point scale where 0 represents "no pain" and 10 represents "pain as bad as you can imagine".

  • Days of analgesic use [ Time Frame: 16 weeks ]
    Analgesic use will be captured daily from enrolment to end of treatment using an eDiary.


Other Outcome Measures:
  • A composite to assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with Sickle cell disease [ Time Frame: 16 weeks ]
    Number of major bleeding or clinically relevant non-major bleeding events AE/ Serious Adverse Events (SAEs), Laboratory Safety Samples

  • Safety of 2 different doses of ticagrelor versus placebo in patients with Sickle cell disease by assessment of blood pressure [ Time Frame: 16 weeks ]
    Unit of Measure: mmHg

  • Safety of 2 different doses of ticagrelor versus placebo in patients with Sickle cell disease by assessment of pulse rate [ Time Frame: 16 weeks ]
    Unit of Measure: beats per minute (bpm)


Enrollment: 194
Study Start Date: July 2015
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
United States, Florida
Research Site
Miami, Florida, United States
United States, Maryland
Research Site
Bethesda, Maryland, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
Egypt
Research Site
Alexandria, Egypt
Research Site
Cairo, Egypt
France
Research Site
Bordeaux Cedex, France
Research Site
PARIS Cedex 15, France
Research Site
Strasbourg, France
Italy
Research Site
Genova, Italy
Research Site
Palermo, Italy
Research Site
Verona, Italy
Kenya
Research Site
Kisian, Kenya
Research Site
Kisumu, Kenya
Research Site
Nairobi, Kenya
Lebanon
Research Site
Beirut, Lebanon
Turkey
Research Site
Adana, Turkey
Research Site
Mersin, Turkey
Research Site
Van, Turkey
United Kingdom
Research Site
Harrow, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Maria Ignacia -Berraondo, MD Quintiles, Inc.
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02482298     History of Changes
Other Study ID Numbers: D5136C00008
First Submitted: June 17, 2015
First Posted: June 26, 2015
Last Update Posted: November 15, 2017
Last Verified: December 2016

Keywords provided by AstraZeneca:
Sickle cell disease
Young adults
Hestia2
Ticagrelor

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs