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
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the effectiveness of once daily versus twice daily aspirin dosing in patients with high-risk myeloproliferative neoplasms (MPN) who show laboratory aspirin resistance. The study aims to determine whether increasing the aspirin dose improves resistance and reduces the risk of blood clots. It is a phase 3, prospective, randomized trial focused on patients with Philadelphia-negative MPN taking low-dose aspirin who have confirmed aspirin resistance through platelet function tests. Participants will be randomly assigned to receive either 81 mg of aspirin once daily or 81 mg twice daily. Platelet function will be tested using light transmission aggregometry (LTA) at one month and six months after starting treatment, with an additional PFA200 test performed at enrollment for comparison. The study will monitor clinical outcomes such as thrombosis events and side effects from aspirin over a follow-up period of at least two years. Throughout the study, patients will be regularly evaluated for blood clotting complications, bleeding events, and any adverse reactions related to aspirin use. Researchers will collect data on these outcomes to compare the two dosing schedules. The main measure of success is the prevalence of aspirin resistance at one and six months. The study duration includes initial testing, treatment periods, and long-term follow-up to assess safety and effectiveness.
CONDITIONS
Official 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 patients aged 18 years or older
- Currently taking aspirin at 81 mg per day
- Laboratory confirmed aspirin resistance by light transmission aggregometry (LTA) method
You will not qualify if you...
- Having other active cancer or cured of cancer less than 6 months ago
- Platelet count less than 50,000 per microliter
- Receiving anticoagulant treatment
- Active peptic ulcer
- Active bleeding or planning a procedure with bleeding risk
- No laboratory aspirin resistance detected by LTA method
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Loading map...
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
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