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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 18, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 17, 2015
First Posted Date  ICMJE June 26, 2015
Results First Submitted Date  ICMJE September 21, 2017
Results First Posted Date  ICMJE December 14, 2017
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE July 9, 2015
Actual Primary Completion Date November 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
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.
Change History Complete list of historical versions of study NCT02482298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: November 14, 2017)
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: June 23, 2015)
  • 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)
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: Dose A
    Intervention: Drug: Ticagrelor
  • Experimental: Dose B
    Intervention: Drug: Ticagrelor
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2017)
87
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2015)
90
Actual Study Completion Date  ICMJE November 16, 2016
Actual Primary Completion Date November 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt,   France,   Italy,   Kenya,   Lebanon,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02482298
Other Study ID Numbers  ICMJE D5136C00008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maria Ignacia -Berraondo, MD Quintiles, Inc.
PRS Account AstraZeneca
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP