Clinical trial NCT03277001: Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD
Official title: Multi-center、Randomize、Open、Non-inferiority Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Exacerbation Copd
Venous Thromboembolism
Keywords: AECOPD
VTE prevention
Rivaroxaban
LMWHs
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 438
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VTE incidence
timeFrame: 1 month
Secondary outcomes:
measure: In-hospital Motality
timeFrame: 1 month
measure: Hospital duration
timeFrame: 1 month
measure: incidence of bleeding
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital,Fudan university
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Shengqing Li, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
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