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CRETA (Clopidogrel Responsiveness in Essential ThrombocithemiA)

NCT07645755 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-06-12

No results posted yet for this study

Summary

Essential thrombocythemia (ET) is a chronic myeloproliferative neoplasm associated with increased platelet production and activation, leading to a high risk of thrombotic complications. Low-dose aspirin is the standard antiplatelet therapy for thrombosis prevention; however, the accelerated platelet turnover characteristic of ET results in rapid recovery of platelet function, making once-daily aspirin insufficient in many patients. Consequently, twice-daily low-dose aspirin is currently recommended to achieve adequate and sustained platelet inhibition.

For patients intolerant to aspirin, clopidogrel 75 mg/day is the approved alternative. Clopidogrel irreversibly inhibits the platelet P2Y12 receptor, but its pharmacodynamic effect is highly variable because it is a prodrug requiring metabolic activation. Studies in non-ET populations have shown that higher clopidogrel doses (150 mg/day) provide stronger and more consistent platelet inhibition without significantly increasing bleeding risk.

Evidence on clopidogrel use in ET is limited, but available data suggest that standard-dose therapy may result in inadequate platelet inhibition, potentially reducing antithrombotic efficacy. Platelet function testing can identify patients with high residual platelet reactivity ("poor responders"), who may benefit from dose escalation. Therefore, in ET patients requiring clopidogrel therapy, assessment of platelet responsiveness may help optimize treatment, ensuring adequate platelet inhibition and potentially improving protection against thrombotic events.

Conditions

  • Essential Thrombocythemia

Interventions

DIAGNOSTIC_TEST

VerifyNow P2Y12 assay

The VerifyNow® system is a commercially available, CE-certified point-of-care device developed to measure P2Y12 receptor-mediated platelet aggregation in whole blood by turbidimetric-based optical detection in patients treated with clopidogrel or other P2Y12 inhibitors.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Elena Rossi · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645755 on ClinicalTrials.gov