Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

Venous Thromboembolism Clinical Trial

— SUPREME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03277001
• Other study ID #: KY2017-279
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2017
• Last updated: September 6, 2017
• Start date: October 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2017
• Source: Huashan Hospital
• Contact: Shengqing Li, Ph D
• Phone: 86-021-52887072
• Email: shengqingli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 438
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation Copd
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban
Rivaroxaban, po. 10mg/day(CrCl= 50 ml/min)or 5 mg /day (CrCl = 30 and < 50 ml/min) po.
• Enoxaparin
Enoxaparin 40mg IH

Locations

Country	Name	City	State
China	Huashan hospital,Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

Akpinar EE, Hosgün D, Akpinar S, Ataç GK, Doganay B, Gülhan M. Incidence of pulmonary embolism during COPD exacerbation. J Bras Pneumol. 2014 Jan-Feb;40(1):38-45. doi: 10.1590/S1806-37132014000100006. English, Portuguese. — View Citation

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. Review. — View 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. — View Citation

Cohen AT, Spiro TE, Büller 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. — View Citation

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. — View Citation

EINSTEIN–PE Investigators, Büller 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. — View Citation

Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JR, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-52. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE incidence	VTE incidence ( include PE and DVT)	1 month
Secondary	In-hospital Motality	in-hospital Motality	1 month
Secondary	Hospital duration	length of hospital stay	1 month
Secondary	incidence of bleeding	incidence of bleeding	1 month