Acute Exacerbation Copd, Venous Thromboembolism
Conditions
Keywords
AECOPD, VTE prevention, Rivaroxaban, LMWHs
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.
Interventions
DRUGRivaroxaban
Rivaroxaban, po. 10mg/day（CrCl≥ 50 ml/min）or 5 mg /day (CrCl ≥ 30 and \< 50 ml/min) po.
DRUGEnoxaparin
Enoxaparin 40mg IH
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VTE incidence | 1 month | VTE incidence ( include PE and DVT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Motality | 1 month | in-hospital Motality |
| Hospital duration | 1 month | length of hospital stay |
| incidence of bleeding | 1 month | incidence of bleeding |
Countries
China
Contacts
Primary ContactShengqing Li, Ph D
Backup ContactYi Gong, Ph D
Outcome results
None listed