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Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

NCT03277001 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2017-09-08

No results posted yet for this study

Summary

AECOPD increases the risk of VTE.VTE prevention is a long way to go for high-risk VTE patients in China.The incidence of AECOPD complicated with VTE in Asian population is high and the mortality rate is high.Rivaroxaban, a new oral anticoagulant, has been widely used in the treatment and prevention of VTE.However the question about the efficacy and safety of new oral anticoagulant compared with LMWHs for the prevention of symptomatic VTE and VTE-related death post-hospital discharge in high-risk AECOPD patients is still unknown. Thus this study is to evaluate if the prophylactic anticoagulation effect by Rivaroxaban is non-inferiority than Enoxaprine in high risk AECOPD and to evaluate the safety of using Rivaroxaban to prevent VTE in high risk AECOPD comparing with Enoxaprine.

Conditions

  • Acute Exacerbation Copd
  • Venous Thromboembolism

Interventions

DRUG

Rivaroxaban

Rivaroxaban, po. 10mg/day（CrCl≥ 50 ml/min）or 5 mg /day (CrCl ≥ 30 and \< 50 ml/min) po.

DRUG

Enoxaparin

Enoxaparin 40mg IH

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Shengqing Li, Ph D · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • China

Study Locations

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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 NCT03277001 on ClinicalTrials.gov