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Large-scale Trial Testing the Intensity of CYTOreductive Therapy in Polycythemia Vera (PV)

NCT01645124 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2012-07-20

No results posted yet for this study

Summary

CYTO-PV is a phase III Prospective, Randomized, Open-label, with Blinded Endpoint evaluation (PROBE), multi-center, clinical trial in patients with diagnosis of Polycythemia vera (PV) treated at the best of recommended therapies (e.g.adequate control of standard cardiovascular risk factors). Irrespective of randomized interventions, all patients will be administered low-dose aspirin (when not contraindicated), i.e.the standard antithrombotic treatment in PV patients.

The purpose of this study to demonstrate that a more intensive cytoreductive therapy, plus low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU), aimed at maintaining hematocrit (HCT) \< 45% is more effective than a less intensive cytoreduction (either with phlebotomy or HU plus low-dose aspirin when not contraindicated) maintaining HCT in the range of 45-50% 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), in patients with Polycythemia Vera treated at the best of recommended therapies (e.g. adequate control of standard cardiovascular risk factors).

Conditions

Interventions

DRUG

Hydroxyurea

PROCEDURE

Phlebotomy

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • A.O. Ospedale Papa Giovanni XXIII

    collaborator OTHER

  • Consorzio Mario Negri Sud

    lead OTHER

Principal Investigators

  • Tiziano Barbui, MD · A.O. Ospedale Papa Giovanni XXIII

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT01645124 on ClinicalTrials.gov