Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD (SUPREME)

Fudan University

Status: Unknown

Conditions: Venous Thromboembolism; Acute Exacerbation Copd

Treatments: Drug: Enoxaparin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT03277001

KY2017-279

Details and patient eligibility

About

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.

Full 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.

Enrollment: 438 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 2 patient groups

Enoxaparin

Active Comparator group

Description:

AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score \> 4

Treatment:

Drug: Enoxaparin

Rivaroxaban

Experimental group

Description:

AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score \> 4

Treatment:

Drug: Rivaroxaban