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

NCT02482298 | Completed Phase 2 Results

• 1 other identifier: D5136C00008
• Study Type: interventional
• Target: 87
• Locations: 8 countries
• Sites: 20

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

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease; Young adults; Hestia2; Ticagrelor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Average of the Daily Worst Pain Values Reported Via eDiary

  Baseline through Week 12

• Change in Proportion of Days With Analgesic Use Measured by an eDiary

  Baseline through Week 12

Other Outcomes (2)

• Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients)

  Baseline through Week 12

• Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events)

  Baseline through Week 12

Study Arms (3)

Dose A

EXPERIMENTAL

Drug: Ticagrelor

Dose B

EXPERIMENTAL

Drug: Ticagrelor

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ticagrelor 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 A; Dose B

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Research Site

Miami, Florida, 33136, United States

Location

Research Site

Bethesda, Maryland, 20817, United States

Location

Research Site

Charleston, South Carolina, 29425, United States

Location

Research Site

Alexandria, 21131, Egypt

Location

Research Site

Cairo, 11562, Egypt

Location

Research Site

Cairo, 11566, Egypt

Location

Research Site

Bordeaux, 33076, France

Location

Research Site

Strasbourg, 67091, France

Location

Research Site

Verona, 37134, Italy

Location

Research Site

Kikuyu, 00100, Kenya

Location

Research Site

Kisian, 40100, Kenya

Location

Research Site

Nairobi, 40100, Kenya

Location

Research Site

Beirut, 1107 2020, Lebanon

Location

Research Site

Beirut, 113-6044, Lebanon

Location

Research Site

Adana, 01130, Turkey (Türkiye)

Location

Research Site

Mersin, 33079, Turkey (Türkiye)

Location

Research Site

Van, 65080, Turkey (Türkiye)

Location

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

Research Site

London, E1 1BB, United Kingdom

Location

Research Site

London, E9 6SR, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Brilinta Global Clinical Leader
• Organization: AstraZeneca

+46 31 776 10 00

Study Officials

• Maria Ignacia -Berraondo, MD

  Quintiles, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 26, 2015
• Study Start: July 9, 2015
• Primary Completion: November 16, 2016
• Study Completion: November 16, 2016
• Last Updated: December 19, 2018
• Results First Posted: December 14, 2017

Record last verified: 2018-11

Locations

EG (3); US (3); KE (3); LE (2); TU (3); GB (3); IT (1); FR (2)