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Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban

NCT02746185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2018-08-13

No results posted yet for this study

Summary

The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.

Conditions

Interventions

DRUG

rivaroxaban

rivaroxaban, 15 mg BD (Bis in die) for 3 weeks followed by 20mg OD (Omni die) for 9 weeks

DRUG

Low-molecular-weight heparin

dalteparin, 200 IU/kg OD for 4 weeks followed by 150 IU/kg OD for 8 weeks

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Guy Meyer, MD · APHP - HEGP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-25
Completion
2018-04-25

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02746185 on ClinicalTrials.gov