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Acute Exacerbation CopdSUPREMENCT03277001

Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

A study testing Rivaroxaban and Enoxaparin in people with Acute Exacerbation Copd and Venous Thromboembolism, run by Huashan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Rivaroxaban and Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
1 siteChina
Study dates
1 Oct 2017to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Shengqing Li, Ph D contact

86-021-52887072

shengqingli@hotmail.com

Yi Gong, Ph D contact

86-021-52887072

gongyi1978@hotmail.com

China1 site

  • Huashan hospital,Fudan university

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Rivaroxaban, Enoxaparin
Keywords
AECOPD, VTE prevention, Rivaroxaban, LMWHs
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

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

  • EnoxaparinDrug

    Enoxaparin 40mg IH

Study groups in NCT03277001
Study groupRoleWhat they receive
EnoxaparinActive comparatorAECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score > 4
Receives: Drug: Enoxaparin
RivaroxabanExperimentalAECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score > 4
Receives: Drug: Rivaroxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VTE incidence

    VTE incidence ( include PE and DVT)

    Measured: 1 month

Secondary outcomes (3)

  1. In-hospital Motality

    in-hospital Motality

    Measured: 1 month

  2. Hospital duration

    length of hospital stay

    Measured: 1 month

  3. incidence of bleeding

    incidence of bleeding

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2017
  2. Study start1 Oct 2017 (estimated)
  3. Primary completion31 Jul 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
438 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03277001
Sponsor's protocol ID
KY2017-279
Acronym
SUPREME
Status last verified
Sep 2017
First submitted
2 Sep 2017
Last updated
8 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27522956

  • 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.

    PubMed 24124736

  • 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.

    PubMed 24626268

  • 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.

    PubMed 26867832

  • 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.

    PubMed 26554770

  • 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.

    PubMed 22449293

  • 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.

    PubMed 25093014

  • 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.

    PubMed 23388003

  • 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.

    PubMed 22023098

Questions about this trial

What is this clinical trial studying?

A study testing Rivaroxaban and Enoxaparin in people with Acute Exacerbation Copd and Venous Thromboembolism, run by Huashan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shengqing Li, Ph D (86-021-52887072, shengqingli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VTE incidence (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03277001, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.

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