Myeloproliferative Neoplasms (MPN)
Conditions
Keywords
myeloproliferative neoplasm, aspirin resistance
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.
Interventions
DRUG81-mg aspirin once daily
81-mg aspirin once daily
DRUG81-mg aspirin twice daily
81-mg aspirin twice daily
Sponsors
Siriraj Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of aspirin resistance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of thrombotic events | 2 years | The thrombotic events will be recorded for at least 2 years after intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The cut-of-point of PFA200 to define aspirin resistance | 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. |
Countries
Thailand
Contacts
Primary ContactYingyong Chinthammitr, MD, RCPT, Thai board of hemato
Outcome results
None listed