NCT03277001

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

September 2, 2017

Last Update Submit

September 6, 2017

Conditions

Acute Exacerbation CopdVenous Thromboembolism

Keywords

AECOPDVTE preventionRivaroxabanLMWHs

Outcome Measures

Primary Outcomes (1)

  • VTE incidence

    VTE incidence ( include PE and DVT)

    1 month

Secondary Outcomes (3)

  • In-hospital Motality

    1 month

  • Hospital duration

    1 month

  • incidence of bleeding

    1 month

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

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

Drug: Enoxaparin

Rivaroxaban

EXPERIMENTAL

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

Drug: Rivaroxaban

Interventions

RivaroxabanDRUG

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

Rivaroxaban
EnoxaparinDRUG

Enoxaparin 40mg IH

Enoxaparin

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization；Padua score \> 4；Age from 40-80y

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (9)

  • Aleva FE, Voets LWLM, Simons SO, de Mast Q, van der Ven AJAM, Heijdra YF. Prevalence and Localization of Pulmonary Embolism in Unexplained Acute Exacerbations of COPD: A Systematic Review and Meta-analysis. Chest. 2017 Mar;151(3):544-554. doi: 10.1016/j.chest.2016.07.034. Epub 2016 Aug 12.

    PMID: 27522956BACKGROUND

  • 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.

    PMID: 24124736BACKGROUND

  • 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.

    PMID: 24626268BACKGROUND

  • 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.

    PMID: 26867832BACKGROUND

  • 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.

    PMID: 26554770BACKGROUND

  • 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.

    PMID: 22449293BACKGROUND

  • 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.

    PMID: 25093014BACKGROUND

  • 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.

    PMID: 23388003BACKGROUND

  • Duran A, Sengupta N, Diamantopoulos A, Forster F, Kwong L, Lees M. Cost and outcomes associated with rivaroxaban vs enoxaparin for the prevention of postsurgical venous thromboembolism from a US payer's perspective. J Med Econ. 2011;14(6):824-34. doi: 10.3111/13696998.2011.623203. Epub 2011 Oct 24.

    PMID: 22023098BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

RivaroxabanEnoxaparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Shengqing Li, Ph D

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, Ph D

CONTACT

86-021-52887072shengqingli@hotmail.com

Yi Gong, Ph D

CONTACT

86-021-52887072gongyi1978@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician, Professor-levelled doctor

Study Record Dates

First Submitted

September 2, 2017

First Posted

September 8, 2017

Study Start

October 1, 2017

Primary Completion

July 31, 2019

Study Completion

December 31, 2019

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

CN(1)