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

December 23, 2024 updated by: Yingyong Chinthammitr, Siriraj Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yingyong Chinthammitr, MD, RCPT, Thai board of hemato
  • Phone Number: +66 + 0814264252
  • Email: dryingyong@gmail.com

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital
        • Contact:
        • Contact:
          • Tarinee Rungjirajitttranon, MD, Thai board of hematology
          • Phone Number: +66-097-051-2132
          • Email: taitharee@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 81-mg aspirin once daily
Drug: 81-mg aspirin once daily
81-mg aspirin once daily
Experimental: 81-mg aspirin twice daily
Drug: 81-mg aspirin twice daily
81-mg aspirin twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of aspirin resistance
Time Frame: 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.
At 1 month and 6 month after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of thrombotic events
Time Frame: 2 years
The thrombotic events will be recorded for at least 2 years after intervention.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cut-of-point of PFA200 to define aspirin resistance
Time Frame: 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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 14, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Siriraj Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

basic characteristic

IPD Sharing Time Frame

1 Jan 2027 (start date) to 31 March 2027 (end date)

IPD Sharing Access Criteria

Hematologists in academic centers, basic characteristic and result, contact via my email address

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myeloproliferative Neoplasms (MPN)

Clinical Trials on 81-mg aspirin once daily

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe