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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

NCT ID: NCT02482298

Last Updated: 2018-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-09

Study Completion Date

2016-11-16

Brief Summary

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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

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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).

Conditions

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Sickle Cell Disease

Keywords

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Sickle cell disease Young adults Hestia2 Ticagrelor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose A

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

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.

Dose B

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Ignacia -Berraondo, MD

Role: STUDY_DIRECTOR

Quintiles, Inc.

Locations

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Research Site

Miami, Florida, United States

Site Status

Research Site

Bethesda, Maryland, United States

Site Status

Research Site

Charleston, South Carolina, United States

Site Status

Research Site

Alexandria, , Egypt

Site Status

Research Site

Cairo, , Egypt

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Cairo, , Egypt

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Bordeaux, , France

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Strasbourg, , France

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Verona, , Italy

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Research Site

Kikuyu, , Kenya

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Kisian, , Kenya

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Nairobi, , Kenya

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Beirut, , Lebanon

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Beirut, , Lebanon

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Adana, , Turkey (Türkiye)

Site Status

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Mersin, , Turkey (Türkiye)

Site Status

Research Site

Van, , Turkey (Türkiye)

Site Status

Research Site

Harrow, , United Kingdom

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Research Site

London, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Countries

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United States Egypt France Italy Kenya Lebanon Turkey (Türkiye) United Kingdom

Other Identifiers

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D5136C00008

Identifier Type: -

Identifier Source: org_study_id