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

Primary Purpose

Acute Exacerbation Copd, Venous Thromboembolism

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Rivaroxaban

Enoxaparin

About this trial

This is an interventional treatment trial for Acute Exacerbation Copd focused on measuring AECOPD, VTE prevention, Rivaroxaban, LMWHs

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Huashan hospital,Fudan university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enoxaparin

Rivaroxaban

Arm Description

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

Outcomes

Primary Outcome Measures

VTE incidence

VTE incidence ( include PE and DVT)

Secondary Outcome Measures

In-hospital Motality

in-hospital Motality

Hospital duration

length of hospital stay

incidence of bleeding

Full Information

NCT ID

NCT03277001

First Posted

September 2, 2017

Last Updated

September 6, 2017

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03277001

Brief Title

Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

Acronym

SUPREME

Official Title

Multi-center、Randomize、Open、Non-inferiority Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

July 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Exacerbation Copd, Venous Thromboembolism

Keywords

AECOPD, VTE prevention, Rivaroxaban, LMWHs

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

438 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Enoxaparin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Rivaroxaban

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

Enoxaparin 40mg IH

Primary Outcome Measure Information:

Title

VTE incidence

Description

VTE incidence ( include PE and DVT)

Time Frame

1 month

Secondary Outcome Measure Information:

Title

In-hospital Motality

Description

in-hospital Motality

Time Frame

1 month

Title

Hospital duration

Description

length of hospital stay

Time Frame

1 month

Title

incidence of bleeding

Description

incidence of bleeding

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shengqing Li, Ph D

Phone

86-021-52887072

shengqingli@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Gong, Ph D

Phone

86-021-52887072

gongyi1978@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shengqing Li, Ph D

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huashan hospital,Fudan university

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

27522956

Citation

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Results Reference

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PubMed Identifier

24124736

Citation

Wang F, Cheng ZZ, Wang JL, Han WZ, Sun NN. [Incidence of pulmonary embolism in patients with acute exacerbations of chronic obstructive pulmonary disease: a meta-analysis]. Zhonghua Yi Xue Za Zhi. 2013 Jun 25;93(24):1868-71. Chinese.

Results Reference

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PubMed Identifier

24626268

Citation

Akpinar EE, Hosgun D, Akpinar S, Atac GK, Doganay B, Gulhan M. Incidence of pulmonary embolism during COPD exacerbation. J Bras Pneumol. 2014 Jan-Feb;40(1):38-45. doi: 10.1590/S1806-37132014000100006.

Results Reference

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PubMed Identifier

26867832

Citation

Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum In: Chest. 2016 Oct;150(4):988.

Results Reference

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PubMed Identifier

26554770

Citation

Chen CY, Liao KM. The Incidence of Deep Vein Thrombosis in Asian Patients With Chronic Obstructive Pulmonary Disease. Medicine (Baltimore). 2015 Nov;94(44):e1741. doi: 10.1097/MD.0000000000001741.

Results Reference

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PubMed Identifier

22449293

Citation

EINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.

Results Reference

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PubMed Identifier

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Citation

Ageno W, Mantovani LG, Haas S, Kreutz R, Haupt V, Schneider J, Turpie AG. XALIA: rationale and design of a non-interventional study of rivaroxaban compared with standard therapy for initial and long-term anticoagulation in deep vein thrombosis. Thromb J. 2014 Jul 14;12:16. doi: 10.1186/1477-9560-12-16. eCollection 2014.

Results Reference

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PubMed Identifier

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Citation

Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

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Citation

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Results Reference

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Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

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