NCT Number: NCT06740916
Patients with myeloproliferative neoplasm (MPN) could have laboratory aspirin resistance and then increasing dose of aspirin from once daily to twice daily regimen is suggested. However, it is not routinely recommended to perform platelet function testing to determine aspirin resistance in MPN patients. Moreover, it is not known whether increasing dose of aspirin would always correct aspirin resistance and significantly prevent the thrombotic events in MPN patients. Therefore, this study aims to compare the efficacy of once daily versus twice daily aspirin in high-risk MPN patients with aspirin resistance. MPN patients with laboratory aspirin resistance will be included in this prospective randomized study and platelet function testing will be repeated at one and six months later. Clinical thrombosis and side effect from aspirin will be recorded for at least 2 years after intervention.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Bangkok Noi, Bangkok, 10700, Thailand
Location status: Recruiting
Tarinee Rungjirajitttranon, MD, Thai board of hematology
CONTACT
Yingyong Chinthammitr, MD
CONTACT
+66 + 0814264252
Inclusion criteria
included adult (>=18 years) Philadelphia-negative MPN patients taking aspirin (81 mg/day). Exclusion criteria included concomitant active cancer, thrombocytopenia (platelet less than 50,000/uL), taking anticoagulant, platelet function test (LTA method) showing no aspirin resistance, active gastric disease, active bleeding. Termination criteria included not taking aspirin regularly, serious side effect from aspirin. Block of four randomization is used. LTA testing is repeated at month 1 and 6 in both arms. PFA200 method is also done at initial enrollment for comparison with LTA method. Follow-up outcome data of clinical thrombosis, bleeding complication and adverse events related with aspirin are collected. Comparative analysis of outcome data is performed between two arms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
81-mg aspirin once daily
81-mg aspirin twice daily
Time frame: At 1 month and 6 month after intervention
Laboratory aspirin resistance is determined by light transmission aggregometry using arachidonic acid (0.5 g/L) as agonist and result of aggregation >= 20% is defined as resistance.
Time frame: 2 years
The thrombotic events will be recorded for at least 2 years after intervention.
Time frame: At enrollment
The standard definition of aspirin resistance in this study is determined by light transmission aggregometry (LTA) using arachidonic acid (0.5 g/L) as agonist and the result of aggregation of >=20% is defined as aspirin resistance. PFA200 is used in parallel with LTA method to determine the concordance of these two methods and to determine the appropriate cut-of-point of PFA200 method to define aspirin resistance.
Contact information is provided by the study sponsor or research team.
Siriraj Hospital
Other
Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk Myeloproliferative Neoplasms Patients With Aspirin Resistance
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