Last reviewed · How we verify

NCT02482298: Hestia2

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

Completed Phase 2 Results posted Last updated 19 December 2018
What this trial tests

Phase 2 trial testing Ticagrelor in Sickle Cell Disease in 87 participants. Completed in 16 November 2016.

Timeline
9 July 2015
Primary endpoint
16 November 2016
16 November 2016

Quick facts

Lead sponsorAstraZeneca
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment87
Start date9 July 2015
Primary completion16 November 2016
Estimated completion16 November 2016
Sites20 locations across France, Italy, Turkey (Türkiye), United Kingdom, Lebanon, Kenya, United States, Egypt

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 30, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary Primary · 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.

GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID-0.1802-0.2673 – -0.0931
TICAGRELOR 10MG BID + PLACEBO 45MG BID-0.1352-0.2260 – -0.0444
TICAGRELOR 45MG BID + PLACEBO 10MG BID-0.1001-0.1881 – -0.0121
Average of the Daily Worst Pain Values Reported Via eDiary Secondary · 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.

GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID1.02± 1.106
TICAGRELOR 10MG BID + PLACEBO 45MG BID1.15± 1.547
TICAGRELOR 45MG BID + PLACEBO 10MG BID1.74± 2.277
Change in Proportion of Days With Analgesic Use Measured by an eDiary Secondary · 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.

GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID-0.1991-0.2753 – -0.1230
TICAGRELOR 10MG BID + PLACEBO 45MG BID-0.0799-0.1590 – -0.0008
TICAGRELOR 45MG BID + PLACEBO 10MG BID-0.1016-0.1782 – -0.0250
Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients) Secondary · Baseline through Week 12

To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD

Patients with any bleeding events
GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID2
TICAGRELOR 10MG BID + PLACEBO 45MG BID2
TICAGRELOR 45MG BID + PLACEBO 10MG BID2
Pts w/ any bleeding event requiring intervention
GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID2
TICAGRELOR 10MG BID + PLACEBO 45MG BID1
TICAGRELOR 45MG BID + PLACEBO 10MG BID2
Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events) Secondary · Baseline through Week 12

To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD

Total number of bleeding events
GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID2
TICAGRELOR 10MG BID + PLACEBO 45MG BID2
TICAGRELOR 45MG BID + PLACEBO 10MG BID2
Maximum severity of bleeding event: Minor
GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID0
TICAGRELOR 10MG BID + PLACEBO 45MG BID1
TICAGRELOR 45MG BID + PLACEBO 10MG BID0
Max sever. of bleed event: Clin-relevant nonmajor
GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID2
TICAGRELOR 10MG BID + PLACEBO 45MG BID1
TICAGRELOR 45MG BID + PLACEBO 10MG BID2
Maximum severity of bleeding event: Major
GroupValue95% CI
PLACEBO 10MG BID + PLACEBO 45MG BID0
TICAGRELOR 10MG BID + PLACEBO 45MG BID0
TICAGRELOR 45MG BID + PLACEBO 10MG BID0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PLACEBO 10MG BID + PLACEBO 45MG BID
Serious: 6/30 (20%)
Deaths:
TICAGRELOR 10MG BID + PLACEBO 45MG BID
Serious: 6/26 (23%)
Deaths:
TICAGRELOR 45MG BID + PLACEBO 10MG BID
Serious: 5/30 (17%)
Deaths:

Serious adverse events (14 terms)

ReactionSystemPLACEBO 10MG BID + PLACEBO…TICAGRELOR 10MG BID + PLAC…TICAGRELOR 45MG BID + PLAC…
Sickle cell anaemia with crisisBlood and lymphatic system disorders
GastroenteritisInfections and infestations
ReticulocytopeniaBlood and lymphatic system disorders
Local swellingGeneral disorders
Hepatic ischaemiaHepatobiliary disorders
CellulitisInfections and infestations
Lower respiratory tract infectionInfections and infestations
Face injuryInjury, poisoning and procedural complications
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
Acute chest syndromeRespiratory, thoracic and mediastinal disorders
Vascular occlusionVascular disorders
Other adverse events (21 terms — click to expand)

ReactionSystemPLACEBO 10MG BID + PLACEBO…TICAGRELOR 10MG BID + PLAC…TICAGRELOR 45MG BID + PLAC…
HeadacheNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
Abdominal painGastrointestinal disorders
Non-cardiac chest painGeneral disorders
PneumoniaInfections and infestations
Upper respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
NauseaGastrointestinal disorders
Musculoskeletal painMusculoskeletal and connective tissue disorders
Sickle cell anaemia with crisisBlood and lymphatic system disorders
ToothacheGastrointestinal disorders
VomitingGastrointestinal disorders
FatigueGeneral disorders
PainGeneral disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
DysmenorrhoeaReproductive system and breast disorders
CoughRespiratory, thoracic and mediastinal disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Sickle cell anaemia with crisis, Gastroenteritis, Reticulocytopenia, Local swelling, Hepatic ischaemia, Cellulitis, Lower respiratory tract infection, Face injury.

Data from ClinicalTrials.gov NCT02482298 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neutrophils, platelets, and inflammatory pathways at the nexus of sickle cell disease pathophysiology.
    Zhang D, Xu C, Manwani D, Frenette PS. · · 2016 · cited 295× · PMID 26758915 · DOI 10.1182/blood-2015-09-618538
  2. Recent Advances in the Treatment of Sickle Cell Disease.
    Salinas Cisneros G, Thein SL. · · 2020 · cited 110× · PMID 32508672 · DOI 10.3389/fphys.2020.00435
  3. Beyond hydroxyurea: new and old drugs in the pipeline for sickle cell disease.
    Telen MJ. · · 2016 · cited 90× · PMID 26758919 · DOI 10.1182/blood-2015-09-618553
  4. Sickle Cell Anemia and Its Phenotypes.
    Williams TN, Thein SL. · · 2018 · cited 84× · PMID 29641911 · DOI 10.1146/annurev-genom-083117-021320
  5. Emerging disease-modifying therapies for sickle cell disease.
    Carden MA, Little J. · · 2019 · cited 60× · PMID 31413089 · DOI 10.3324/haematol.2018.207357
  6. Sickle cell disease: an inherited thrombophilia.
    Wun T, Brunson A. · · 2016 · cited 33× · PMID 27913540 · DOI 10.1182/asheducation-2016.1.640
  7. New Therapeutic Options for the Treatment of Sickle Cell Disease.
    Matte A, Zorzi F, Mazzi F, Federti E, et al · · 2019 · cited 27× · PMID 30671208 · DOI 10.4084/mjhid.2019.002
  8. New insights into the pathophysiology and development of novel therapies for sickle cell disease.
    Moerdler S, Manwani D. · · 2018 · cited 24× · PMID 30504350 · DOI 10.1182/asheducation-2018.1.493

Verify or expand the search:

Other trials of Ticagrelor

Trials testing the same drug.

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02482298.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing