Clinical trial NCT06740916: Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk MPN Patients with Aspirin Resistance
Official title: Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk Myeloproliferative Neoplasms Patients with Aspirin Resistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myeloproliferative Neoplasms (MPN)
Keywords: myeloproliferative neoplasm
aspirin resistance
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Philadelphia negative Myeloproliferative neoplasms aged at least 18 years old

Exclusion Criteria:

* Concomitant other active malignancy or cured less than 6 months
* Platelet count less than 50,000/microL
* Receiving anticoagulant
* Active peptic ulcer
* Active bleeding or Planning to undergo procedure/operation with bleeding risk
* No laboratory aspirin resistance with LTA method

Primary outcomes:
measure: prevalence of aspirin resistance
timeFrame: At 1 month and 6 month after intervention
Secondary outcomes:
measure: The incidence of thrombotic events
timeFrame: 2 years
Other outcomes:
measure: The cut-of-point of PFA200 to define aspirin resistance
timeFrame: At enrollment
Locations:
city: Bangkok Noi
country: Thailand
facility: Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
References:
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citation: Pascale S, Petrucci G, Dragani A, Habib A, Zaccardi F, Pagliaccia F, Pocaterra D, Ragazzoni E, Rolandi G, Rocca B, Patrono C. Aspirin-insensitive thromboxane biosynthesis in essential thrombocythemia is explained by accelerated renewal of the drug target. Blood. 2012 Apr 12;119(15):3595-603. doi: 10.1182/blood-2011-06-359224. Epub 2012 Jan 10.
citation: Dillinger JG, Sideris G, Henry P, Bal dit Sollier C, Ronez E, Drouet L. Twice daily aspirin to improve biological aspirin efficacy in patients with essential thrombocythemia. Thromb Res. 2012 Jan;129(1):91-4. doi: 10.1016/j.thromres.2011.09.017. Epub 2011 Oct 19. No abstract available.