Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

Not Applicable

• Conditions: Acute Exacerbation Copd; Venous Thromboembolism
• Interventions: Drug: Enoxaparin; Drug: Rivaroxaban

• Registration Number: NCT03277001
• Lead Sponsor: Huashan Hospital

Brief 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.

Detailed Description

The acute exacerbation of COPD increases the risk of venous thromboembolism.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.

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-02
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08
• Study Start: 2017-10-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

• AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization；Padua score > 4；Age from 40-80y

Exclusion Criteria

• Patients whose admitting diagnosis was VTE；Patients whose duration of hospital stay was <3 days or >30 days ；Patients who received therapeutic doses of anticoagulants or thrombolytic therapy for any indication before hospitalization；an organic lesion that could bleed; severe liver or renal failure; confirmed or uncontrolled hypertension; a congenital or acquired coagulation disorder; a history of hypersensitivity or thrombocytopenia to heparins of any type；Patients who were contraindicated to anticoagulant therapy, venography, or angiography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin	AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score \> 4
Rivaroxaban	Rivaroxaban	AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score \> 4

Primary Outcome Measures

Name	Time	Method
VTE incidence	1 month	VTE incidence ( include PE and DVT)

Secondary Outcome Measures

Name	Time	Method
Hospital duration	1 month	length of hospital stay
In-hospital Motality	1 month	in-hospital Motality
incidence of bleeding	1 month	incidence of bleeding

Trial Locations

Locations (1)

Huashan hospital,Fudan university; 🇨🇳 Shanghai, Shanghai, China