Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk MPN Patients with Aspirin Resistance

NCT06740916 | Recruiting Phase 3

• 1 other identifier: Siriraj Hospital
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloproliferative Neoplasms (MPN)

Keywords

myeloproliferative neoplasm; aspirin resistance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The incidence of thrombotic events

  2 years

Other Outcomes (1)

• The cut-of-point of PFA200 to define aspirin resistance

  At enrollment

Study Arms (2)

81-mg aspirin once daily

ACTIVE COMPARATOR

81-mg aspirin once daily

Drug: 81-mg aspirin once daily

81-mg aspirin twice daily

EXPERIMENTAL

81-mg aspirin twice daily

Drug: 81-mg aspirin twice daily

Interventions

81-mg aspirin once daily DRUG

81-mg aspirin once daily

81-mg aspirin once daily

81-mg aspirin twice daily DRUG

81-mg aspirin twice daily

81-mg aspirin twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Philadelphia negative Myeloproliferative neoplasms aged at least 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (5)

• 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.

  PMID: 38877813 BACKGROUND

• 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.

  PMID: 32266380 BACKGROUND

• 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.

  PMID: 18430462 BACKGROUND

• 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.

  PMID: 22234683 BACKGROUND

• 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.

  PMID: 22014557 BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yingyong Chinthammitr, MD, RCPT, Thai board of hemato

CONTACT

+66 + 0814264252; dryingyong@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 Jan 2027 (start date) to 31 March 2027 (end date)
• Access Criteria: Hematologists in academic centers, basic characteristic and result, contact via my email address

Locations

TH (1)