CRETA (Clopidogrel Responsiveness in Essential ThrombocithemiA) (CRETA)
Evaluation of Response to Clopidogrel in Patients With Essential Thrombocythemia
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Elena Rossi
- Telefoonnummer: +39 0630154206
- E-mail: elena.rossi@policlinicogemelli.it
Studie Locaties
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Pescara, Italië, 65124
- Azienda USL di Pescara - Ospedale Santo Spirito
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Contact:
- Paola Ranalli
- E-mail: paola.ranalli@asl.pe.it
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Hoofdonderzoeker:
- Paola Ranalli
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Torino, Italië, 10126
- AOU Citta della Salute e della Scienza di Torino
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Hoofdonderzoeker:
- Eloise Beggiato
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Contact:
- Eloise Beggiato
- E-mail: ebeggiato@cittadellasalute.to.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Consecutive Patients with ET, with an approved indication for clopidogrel therapy (i.e., aspirin intolerance) and a documented good or poor response to the standard 75 mg od dose of clopidogrel at maintenance, as assessed by the standard VN-P2Y12 poinr of care, platelet function test.
At least 50 patients will be enrolled, based on the current records of the participating Centers.
Beschrijving
Inclusion Criteria:
- Male or female subjects age ≥ 18 years;
- Confirmed diagnosis of ET according to the 2022 WHO classification criteria30;
- Patients treated with clopidogrel 75 mg od as antithrombotic prophylaxis since at least 3 weeks, as per the indication of the referring hematologist;
- Ability to understand the nature of the study and voluntarily provide written informed consent patients whose responsiveness to the standard clopidogrel regimen was determined, based on clinical practice, using the VN-P2Y12 method.
Exclusion Criteria:
- Platelet count >1,000,000/μL on three separate determinations within the 2 months prior to enrollment;
- Need for anticoagulant therapy;
- Concomitant use of other antiplatelet agents;
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) (i.e > 3 days per week);
- Chronic corticosteroid therapy exceeding a daily dose equivalent to prednisone 5 mg
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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pharmacodynamic effectiveness of different clopidogrel dosing
Tijdsspanne: 15 days
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To assess the pharmacodynamic effectiveness of an optimised clopidogrel dosing (75 mg bid) in ET patients with documented poor responsiveness to 75 mg od.
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15 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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proportion of patients ET treated with standard-dose clopidogrel
Tijdsspanne: 15 days
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To estimate the proportion of patients ET treated with standard-dose clopidogrel (75 mg once daily) who exhibit poor pharmacodynamic response to clopidogrel across
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15 days
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consistency over time of pharmacodynamic response
Tijdsspanne: 15 days
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To assess the consistency over time of pharmacodynamic response in patients who are documented as good responders to clopidogrel 75 mg once daily with validated platelet function assays.
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15 days
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Elena Rossi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 27515
Informatie over medicijnen en apparaten, studiedocumenten
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