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Clinical Trials/EUCTR2014-000305-13-IT
EUCTR2014-000305-13-ITActive, not recruitingPhase 1

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER) - MARINER

Janssen-Cilag International NV0 sites8,000 target enrollmentStarted: June 12, 2014Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
8,000
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Must be hospitalized at least 3 consecutive days and up to 14 days for an acute medical condition such as congestive heart failure, acute respiratory insufficiency or acute exacerbation of chronic obstructive pulmonary disease, acute ischemic stroke, acute infectious diseases or inflammatory diseases, including rheumatic disease
  • •Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score >=3
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 2700
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5300

Exclusion Criteria

  • •Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
  • •Serious trauma within 4 weeks before randomization
  • •History of hemorrhagic stroke at any time in the past
  • •Severe head trauma within 3 months of randomization
  • •Any medical condition that requires chronic use of any parenteral or oral anticoagulation

Investigators

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