Long-term pharmacodynamic and clinical effects of twice- versus once-daily low-dose aspirin in essential thrombocythemia: The ARES trial.
Bianca Rocca, Alberto Tosetto, Giovanna Petrucci...
https://pubmed.ncbi.nlm.nih.gov/38877813Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06740916
Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk Myeloproliferative Neoplasms Patients With Aspirin Resistance
Led by Siriraj Hospital · Updated on 2024-12-27
240
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the long-term effects of taking aspirin once daily versus twice daily in patients with high-risk myeloproliferative neoplasms (MPN) who show laboratory aspirin resistance. This prospective randomized study aims to see if increasing the aspirin dose helps reduce the risk of blood clots, as it is not known if doubling the dose always corrects aspirin resistance or prevents clotting events. The study includes adults with Philadelphia-negative MPN who already take aspirin but have aspirin resistance confirmed by platelet function tests. Participants are randomly assigned to receive either 81 mg of aspirin once daily or 81 mg twice daily. Platelet function testing using the LTA method will be repeated at one and six months after starting the assigned aspirin regimen to assess aspirin resistance. Additionally, a PFA200 test is performed at enrollment for comparison. The study will record clinical thrombosis events and any side effects related to aspirin use over at least two years. During the study, participants will undergo platelet function testing at set intervals and will be monitored for signs of blood clots, bleeding complications, and any adverse effects from aspirin. Researchers will analyze and compare the outcomes between the two aspirin dosing groups. Follow-up will continue for at least two years to gather comprehensive data on the incidence of thrombotic events and safety.
CONDITIONS
Brief Title
Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk MPN Patients With Aspirin Resistance
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Philadelphia-negative myeloproliferative neoplasm diagnosed
- Age 18 years or older
- Taking aspirin 81 mg/day
- Laboratory confirmed aspirin resistance by LTA method
You will not qualify if you...
- Having any other active cancer or cured within the last 6 months
- Platelet count below 50,000/microL
- Currently receiving anticoagulant treatment
- Active peptic ulcer disease
- Active bleeding or scheduled for procedures with bleeding risk
- No aspirin resistance detected by LTA method
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial laboratory testing including platelet function tests
Treatment
Duration - Up to 2 years
Participants receive either 81-mg aspirin once daily or twice daily to evaluate the efficacy in high-risk MPN patients with aspirin resistance.
Visits at enrollment, 1 month, and 6 months for aspirin resistance testing; additional follow-up visits for outcome assessments
Follow-up
Duration - Up to 2 years
Participants are monitored for thrombotic events, bleeding complications, and adverse events related to aspirin after treatment.
Regular visits for clinical outcome data collection throughout the study duration
Trial Site Locations
Total: 1 location
1
Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
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Research Team
Y
Yingyong Chinthammitr, MD, RCPT, Thai board of hemato
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia.
Bianca Rocca, Alberto Tosetto, Silvia Betti...
https://pubmed.ncbi.nlm.nih.gov/32266380Monitoring aspirin treatment in patients with thrombocytosis: comparison of the platelet function analyzer (PFA)-100 with optical aggregometry.
Argirios E Tsantes, Georgios Mantzios, Vassiliki Giannopoulou...
https://pubmed.ncbi.nlm.nih.gov/18430462Aspirin-insensitive thromboxane biosynthesis in essential thrombocythemia is explained by accelerated renewal of the drug target.
Silvia Pascale, Giovanna Petrucci, Alfredo Dragani...
https://pubmed.ncbi.nlm.nih.gov/22234683Twice daily aspirin to improve biological aspirin efficacy in patients with essential thrombocythemia.
Jean-Guillaume Dillinger, Georgios Sideris, Patrick Henry...
https://pubmed.ncbi.nlm.nih.gov/22014557