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

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ClinicalTrials.gov Identifier: NCT03277001
Recruitment Status : Not yet recruiting
First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Shengqing Li, Huashan Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation Copd Venous Thromboembolism Drug: Rivaroxaban Drug: Enoxaparin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center、Randomize、Open、Non-inferiority Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Enoxaparin
AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score > 4
Drug: Enoxaparin
Enoxaparin 40mg IH
Experimental: Rivaroxaban
AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score > 4
Drug: Rivaroxaban
Rivaroxaban, po. 10mg/day(CrCl≥ 50 ml/min)or 5 mg /day (CrCl ≥ 30 and < 50 ml/min) po.



Primary Outcome Measures :
  1. VTE incidence [ Time Frame: 1 month ]
    VTE incidence ( include PE and DVT)


Secondary Outcome Measures :
  1. In-hospital Motality [ Time Frame: 1 month ]
    in-hospital Motality

  2. Hospital duration [ Time Frame: 1 month ]
    length of hospital stay

  3. incidence of bleeding [ Time Frame: 1 month ]
    incidence of bleeding



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277001


Contacts
Contact: Shengqing Li, Ph D 86-021-52887072 shengqingli@hotmail.com
Contact: Yi Gong, Ph D 86-021-52887072 gongyi1978@hotmail.com

Locations
China, Shanghai
Huashan hospital,Fudan university
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Huashan Hospital
Investigators
Principal Investigator: Shengqing Li, Ph D Huashan Hospital

Publications:

Responsible Party: Shengqing Li, Chief physician, Professor-levelled doctor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03277001     History of Changes
Other Study ID Numbers: KY2017-279
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shengqing Li, Huashan Hospital:
AECOPD
VTE prevention
Rivaroxaban
LMWHs

Additional relevant MeSH terms:
Embolism and Thrombosis
Thromboembolism
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants