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

Sickle Cell Disease Clinical Trial

— Hestia2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482298
• Other study ID #: D5136C00008
• Status: Completed
• Phase: Phase 2
• Start date: July 9, 2015
• Est. completion date: November 16, 2016

Study information

• Verified date: November 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 16, 2016
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/ß0) 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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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
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

Locations

Country	Name	City	State
Egypt	Research Site	Alexandria
Egypt	Research Site	Cairo
Egypt	Research Site	Cairo
France	Research Site	Bordeaux Cedex
France	Research Site	Strasbourg
Italy	Research Site	Verona
Kenya	Research Site	Kikuyu
Kenya	Research Site	Kisian
Kenya	Research Site	Nairobi
Lebanon	Research Site	Beirut
Lebanon	Research Site	Beirut
Turkey	Research Site	Adana
Turkey	Research Site	Mersin
Turkey	Research Site	Van
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United States	Research Site	Bethesda	Maryland
United States	Research Site	Charleston	South Carolina
United States	Research Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Egypt,  France,  Italy,  Kenya,  Lebanon,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients)	To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD	Baseline through Week 12
Other	Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events)	To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD	Baseline through Week 12
Primary	Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary	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.	Baseline through Week 12
Secondary	Average of the Daily Worst Pain Values Reported Via eDiary	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.	Baseline through Week 12
Secondary	Change in Proportion of Days With Analgesic Use Measured by an eDiary	To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.	Baseline through Week 12