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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 81-mg aspirin once daily | Active Comparator | 81-mg aspirin once daily |
|
| 81-mg aspirin twice daily | Experimental | 81-mg aspirin twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 81-mg aspirin once daily | Drug | 81-mg aspirin once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of aspirin resistance | 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. | At 1 month and 6 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of thrombotic events | The thrombotic events will be recorded for at least 2 years after intervention. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The cut-of-point of PFA200 to define aspirin resistance | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingyong Chinthammitr, MD, RCPT, Thai board of hemato | Contact | +66 + 0814264252 | dryingyong@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38877813 | Result | Rocca B, Tosetto A, Petrucci G, Rossi E, Betti S, Soldati D, Iurlo A, Cattaneo D, Bucelli C, Dragani A, Di Ianni M, Ranalli P, Palandri F, Vianelli N, Beggiato E, Lanzarone G, Ruggeri M, Carli G, Elli EM, Renso R, Randi ML, Bertozzi I, Loscocco GG, Ricco A, Specchia G, Vannucchi AM, Rodeghiero F, De Stefano V, Patrono C; Aspirin Regimens in EsSential thrombocythemia (ARES) Investigators. Long-term pharmacodynamic and clinical effects of twice- versus once-daily low-dose aspirin in essential thrombocythemia: The ARES trial. Am J Hematol. 2024 Aug;99(8):1462-1474. doi: 10.1002/ajh.27418. Epub 2024 Jun 15. | |
| 32266380 |
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basic characteristic
1 Jan 2027 (start date) to 31 March 2027 (end date)
Hematologists in academic centers, basic characteristic and result, contact via my email address
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| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 81-mg aspirin twice daily |
| Drug |
81-mg aspirin twice daily |
|
| At enrollment |
| Result |
| Rocca B, Tosetto A, Betti S, Soldati D, Petrucci G, Rossi E, Timillero A, Cavalca V, Porro B, Iurlo A, Cattaneo D, Bucelli C, Dragani A, Di Ianni M, Ranalli P, Palandri F, Vianelli N, Beggiato E, Lanzarone G, Ruggeri M, Carli G, Elli EM, Carpenedo M, Randi ML, Bertozzi I, Paoli C, Specchia G, Ricco A, Vannucchi AM, Rodeghiero F, Patrono C, De Stefano V. A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia. Blood. 2020 Jul 9;136(2):171-182. doi: 10.1182/blood.2019004596. |
| 18430462 | Result | Tsantes AE, Mantzios G, Giannopoulou V, Tsirigotis P, Bonovas S, Rapti E, Mygiaki E, Kartasis Z, Sitaras NM, Dervenoulas J, Travlou A. Monitoring aspirin treatment in patients with thrombocytosis: comparison of the platelet function analyzer (PFA)-100 with optical aggregometry. Thromb Res. 2008;123(1):100-7. doi: 10.1016/j.thromres.2008.03.008. Epub 2008 Apr 21. |
| 22234683 | Result | 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. |
| 22014557 | Result | 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. |