Phase 2
Completed N=87
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease
Source: ClinicalTrials.gov NCT02482298 ↗Enrolled (actual)
87
Serious AEs
19.8%
Results posted
Dec 2017
Primary outcomePrimary: Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary — -0.1802; -0.1352; -0.1001 Proportion of days with pain
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary |
-0.1802; -0.1352; -0.1001 | — |
| SECONDARY Average of the Daily Worst Pain Values Reported Via eDiary |
1.02; 1.15; 1.74 | — |
| SECONDARY Change in Proportion of Days With Analgesic Use Measured by an eDiary |
-0.1991; -0.0799; -0.1016 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02482298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.