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/32266380/Actively Recruiting
Led by Siriraj Hospital · Updated on 2024-12-27
240
Participants Needed
1
Research Sites
156 weeks
Total Duration
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
Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk MPN Patients With Aspirin Resistance
Y
Yingyong Chinthammitr, MD, RCPT, Thai board of hemato
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Siriraj Hospital
Lead Sponsor
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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
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor