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

NCT ID: NCT06740916

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myeloproliferative Neoplasms (MPN)

Keywords

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myeloproliferative neoplasm aspirin resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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81-mg aspirin once daily

81-mg aspirin once daily

Group Type ACTIVE_COMPARATOR

81-mg aspirin once daily

Intervention Type DRUG

81-mg aspirin once daily

81-mg aspirin twice daily

81-mg aspirin twice daily

Group Type EXPERIMENTAL

81-mg aspirin twice daily

Intervention Type DRUG

81-mg aspirin twice daily

Interventions

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81-mg aspirin once daily

81-mg aspirin once daily

Intervention Type DRUG

81-mg aspirin twice daily

81-mg aspirin twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yingyong Chinthammitr

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Bangkok Noi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Yingyong Chinthammitr, MD, RCPT, Thai board of hemato

Role: CONTACT

Phone: +66 + 0814264252

Email: [email protected]

Facility Contacts

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Yingyong Chinthammitr, MD

Role: primary

Tarinee Rungjirajitttranon, MD, Thai board of hematology

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 38877813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32266380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18430462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22234683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22014557 (View on PubMed)

Other Identifiers

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Siriraj Hospital

Identifier Type: -

Identifier Source: org_study_id