A large-scale trial testing the intensity of CYTOreductive therapy to prevent cardiovascular events In patients with Polycythemia Vera (PV)
A Prospective, Randomized, Open-label, with Blinded Endpoint evaluation (PROBE), multi-center, controlled , clinical trial on the effectiveness of the cytoreductive therapies (i.e. Phlebotomy and Hydroxyurea (HU)) in reducing cardiovascular (CV) deaths and thrombotic events in patients with Polycythemia Vera (PV)
Consorzio Mario Negri Sud
1,000 participants
May 21, 2008
Interventional
Conditions
Summary
To assess the benefit/risk profile of cytoreductive therapy with phlebotomy and/or hydroxyurea (HU) aimed at maintaining hematocrit (HCT) < 45% Vs. maintaining HCT in the range of 45-50% in patients with PV treated at the best of recommended therapies (e.g. low dose of aspirin when indicated and adequated control of standard cardiovascular risk factors)
Eligibility
Inclusion Criteria4
- Age > 18 years
- Diagnosis of PV according to World Health Organisation (WHO) criteria
- Ability and willingness to comply with all study requirements
- Written and signed informed consent
Exclusion Criteria6
- Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
- Known hypersensitivity or contraindication to study treatments
- Significant liver (aspartate amino transferasi (AST) or alanine aminotransferasi (ALT) > 2.5 times upper limit normal (ULN)) or renal disease (creatinine > 2 mg/ml)
- Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
- History of active substance or alcohol abuse within the last year
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol - Baseline and follow-up (F-UP) visits schedule and assessments
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Interventions
To assess the benefit/risk profile of cytoreductive therapy, plus low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU, oral administration) aimed at maintaining hematocrit (HCT) < 45% Vs. maintaining HCT in the range of 45-50% in patients with PV treated at the best of recommended therapies (e.g., low dose of aspirin when indicated and adequate control of standard cardiovascular risk factors).To demonstrate that maintaining HCT < 45% (either with phlebotomy or HidroxyUrea (HU) (standard cytoreduction) is more effective than maintaining HCT in the range of 45-50% (either with phlebotomy or HU) (experimental cytoreduction) in the reduction of CV deaths plus thrombotic events (stroke, acute coronary syndrome [ACS], transient ischemic attack [TIA], pulmonary embolism [PE], splanchnic thrombosis, deep vein thrombosis [DVT], and any other clinically relevant thrombotic event). All patients will be treated with phlebotomy and/or HU with the goal to reach and maintain the target HCT established by randomization. Phlebotomy should be performed initially by removing 250-500 ml of every other day or twice a week until the target HCT is obtained. HU should be administered initially at a dose of 0.5-1.0 g daily. The patient is followed with weekly blood counts adjusting dose to achieve a platelet count < 400,000/mmc. If neutropenia occurs, the dose of HU should be lowered so as not to reduce leukocyte < 3,500/mmc. Blood counts at regular intervals (monthly) will establish the frequency of future phlebotomies with the goal to maintain the target HCT. Supplemental iron therapy should not be given. LENGTH OF STUDY: 5 years
Locations(1)
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ACTRN12609000046202