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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Philadelphia negative Myeloproliferative neoplasms aged at least 18 years old

Disqualifiers

Concomitant other active malignancy or cured less than 6 months

Platelet count less than 50,000/microL

Receiving anticoagulant

Active peptic ulcer

Trial design

Design model

Parallel

Treatments tested in this trial

  • 81-mg aspirin once daily

    Drug

    81-mg aspirin once daily

  • 81-mg aspirin twice daily

    Drug

    81-mg aspirin twice daily

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: 81-mg aspirin once dailyActive comparator 1 intervention
Group B: 81-mg aspirin twice dailyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
At 1 month and 6 month after intervention

Secondary outcomes

1

The incidence of thrombotic events

The thrombotic events will be recorded for at least 2 years after intervention.

Time frame
2 years

Other outcomes

1

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.

Time frame
At enrollment

Sponsors and contacts

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