An interventional study of Rivaroxaban and Enoxaparin in Acute Exacerbation Copd and Venous Thromboembolism, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
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.
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.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 438 is above the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization Padua score \> 4
Drug: Enoxaparin
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.
Enoxaparin 40mg IH
VTE incidence
VTE incidence ( include PE and DVT)
Time frame: 1 month
In-hospital Motality
in-hospital Motality
Time frame: 1 month
Hospital duration
length of hospital stay
Time frame: 1 month
incidence of bleeding
incidence of bleeding
Time frame: 1 month
Start is estimated for Oct 2017; primary completion for Jul 2019, 21 months later.
Of 65 non-industry interventional studies with no phase under Venous Thromboembolism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 21 months is below that.
Counting every sponsor, half of 70 studies reached it within 31 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rivaroxaban