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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Elena Rossi
- 전화번호: +39 0630154206
- 이메일: elena.rossi@policlinicogemelli.it
연구 장소
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Pescara, 이탈리아, 65124
- Azienda USL di Pescara - Ospedale Santo Spirito
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연락하다:
- Paola Ranalli
- 이메일: paola.ranalli@asl.pe.it
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수석 연구원:
- Paola Ranalli
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Torino, 이탈리아, 10126
- AOU Citta della Salute e della Scienza di Torino
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수석 연구원:
- Eloise Beggiato
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연락하다:
- Eloise Beggiato
- 이메일: ebeggiato@cittadellasalute.to.it
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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pharmacodynamic effectiveness of different clopidogrel dosing
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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proportion of patients ET treated with standard-dose clopidogrel
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Elena Rossi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .