Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

NCT ID: NCT03277001

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-12-31

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.

Conditions

Acute Exacerbation Copd; Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enoxaparin

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

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Enoxaparin 40mg IH

Rivaroxaban

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

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

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

Interventions

Rivaroxaban

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

Intervention Type: DRUG

Enoxaparin

Enoxaparin 40mg IH

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengqing Li

Chief physician, Professor-levelled doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shengqing Li, Ph D

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Shengqing Li, Ph D

Role: CONTACT

shengqingli@hotmail.com

86-021-52887072

Yi Gong, Ph D

Role: CONTACT

gongyi1978@hotmail.com

86-021-52887072

References

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Other Identifiers

KY2017-279

Identifier Type: -

Identifier Source: org_study_id