Venous ThromboembolismPhase 3EPICTNCT04066764
Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters
A Phase 3 study testing Rivaroxaban, Warfarin and Nadroparin in people with Venous Thromboembolism, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of new oral anticoagulants and vitamin K antagonists for the anticoagulation for the implantation of vena cava filters in patients with deep venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Rivaroxaban, Warfarin and Nadroparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesChina
- Study dates
- 8 May 2020to 1 Oct 2024
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.
Who cannot join
- Age < 18 years or age > 75 years,
- With obvious contraindications for anticoagulation therapy,
- Allergic to iodine contrast agents in the past,
- Pregnant or breastfeeding women,
- With malignant tumors and life expectancy < 1 year,
- Severe liver diseases (such as acute hepatitis, chronic active hepatitis or cirrhosis) or alanine aminotransferase levels were higher than three times the upper limit of normal.
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- With other diseases that need anticoagulation,
- With previous heparin-induced thrombocytopenia,
- Bacterial endocarditis,
- Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg,
- Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers
- With severe renal insufficiency (creatinine clearance <30 mL/min)
- Allergic to the drug used in this study
- With permanent filter implantation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Yuefeng R Zhu, MD, 13868101010 ext. 13868101010, drzyf@hotmail.com
- Recruiting
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
Zhejie Liu, MD,PhD, 15268135830 ext. 86, lawson3001@gmail.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Zhengdong Fang, MD, 15256990126 ext. 15256990126, fangzhengdong@126.com
- Recruiting
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Wan Zhang, MD, 13916056910 ext. 13916056910, ant0930@163.com
- Recruiting
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, 200000
Bin Gao, MD, 13764979078 ext. 13764979078, doctorgaobin@163.com
- Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Jianing Yue, MD, 13564788422 ext. 86, yuejianing@gmail.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shangdong, 264000
Lubin Li, MD, 18653587255 ext. 18653587255, 278468192@qq.com
About this study
Official title: An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy and safety of new oral anticoagulants and vitamin K antagonists for the anticoagulation for the implantation of vena cava filters in patients with deep venous thrombosis.
Read the detailed description
Deep vein thrombosis (DVT) of lower extremities is a venous reflux disorder caused by abnormal coagulation of deep vein blood. The main adverse consequences of DVT are pulmonary embolism (PE) and post-thrombotic syndrome, which can significantly affect the quality of life of patients and even lead to death. Anticoagulation is the basic treatment of DVT, which can inhibit the spread of thrombus, facilitate thrombus autolysis and recanalization of the lumen, and reduce the incidence and mortality of PE. For patients with contraindications or complications of anticoagulation therapy, the implantation of inferior vena cava filter may be considered. At the same time, patients with the following conditions may be considered for the implantation of inferior vena cava filter: PE is still present in the case of adequate anticoagulant therapy, floating thrombus in the iliac, femoral or inferior vena cava, thrombectomy is planned for acute DVT, and abdominal, pelvic or lower extremity surgery with high risk factors for PE and acute DVT. The current standard treatment regimen for venous thromboembolism (VTE) anticoagulation is low molecular weight heparin (LMWH) combined with or followed by vitamin K antagonist warfarin. It has been proved that low molecular weight heparin has good safety and effectiveness in the prevention and initial treatment of VTE, especially for VTE prevention and treatment in cancer patients and pregnant patients. As a standard oral anticoagulant, warfarin has definite anticoagulant effect and is cheap. However, low molecular weight heparin needs subcutaneous injection, which can cause adverse reactions such as pain, itching, subcutaneous hemorrhage and nodules at the injection site, and some complications such as heparin-induced thrombocytopenia (HIT). Warfarin anticoagulation therapy requires long-term laboratory monitoring of international standardized ratio (INR) and timely adjustment of warfarin dosage according to INR, which will result in difficult follow-up management, poor compliance, uncertainty of warfarin treatment effect, and even serious bleeding complications. According to relevant studies, the incidence of warfarin-related major bleeding is about 1%-2%, and the recurrence or aggravation of thrombus is also high. Rivaroxaban can simplify treatment, and is safe. It's also not easy to interact with food or drugs. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism, and repeated coagulation monitoring is not required. However, Rivaroxaban lacks sufficient clinical data for perioperative adjuvant anticoagulation therapy of filter implantation. Therefore, this study should be carried out to provide the basis for DVT treatment guidelines and explore the clinical indications of rivaroxaban.
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban, Warfarin, Nadroparin
- Keywords
- venous thromboembolism, rivaroxaban, vena cava filters
- 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
Also called Xarelto
15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral
WarfarinDrug
Also called coumadin
3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral
NadroparinDrug
Also called Fraxiparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Participants will receive rivaroxaban 15mg oral twice daily for 3 weeks after operation, later rivaroxaban 20mg oral once daily until 3 months after the filter is retrieved. Receives: Drug: Rivaroxaban |
| Warfarin/ Nadroparin | Active comparator | Participants will receive Nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 3 months after the filter is retrieved. Receives: Drug: Warfarin; Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Percentage of participants with all deaths
Measured: 4 months after the filter is retrieved
Pulmonary embolism related mortality
Measured: 4 months after the filter is retrieved
Percentage of Participants with bleeding
Clinically relevant bleeding is defined as a composite of major or clinically relevant nonmajor bleeding
Measured: 4 months after the filter is retrieved
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism
the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]
Measured: 4 months after the filter is retrieved
Secondary outcomes (3)
Percentage of Participants With IVC Filter Retrieval Failure
IVC filter retrieval failure is relevant to IVC filter complications (e.g. IVC thrombosis, IVC perforation, IVC filter migration or tilting and IVC filter embolization), system factors and technical factors.
Measured: 4 months after the filter is retrieved
Percentage of Participants With an Event for Net Clinical Benefit
composite of primary efficacy outcomes and major bleeding, assessed in the intention-to-treat population.
Measured: 4 months after the filter is retrieved
Percentage of Participants With Other Vascular Events
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, transient ischemic attack, pulmonary embolism, non-central nervous system systemic embolism or vascular death) will be assessed based results/films/images of confirmatory testing, and/or case summaries.
Measured: 4 months after the filter is retrieved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start8 May 2020
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Huadong Hospital, Shanghai Zhongshan Hospital, Shanghai 5th People's Hospital, Yantai Yuhuangding Hospital, Anhui Provincial Hospital
- Responsible party
- Principal investigator, Zhenjie Liu, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Zhejie Liu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066764
- Sponsor's protocol ID
- SAHZhejiangU-002
- Acronym
- EPICT
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, statistical analysis plan and informed consent form will be openly available.
Publications
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 26867832Jain A, Cifu AS. Antithrombotic Therapy for Venous Thromboembolic Disease. JAMA. 2017 May 16;317(19):2008-2009. doi: 10.1001/jama.2017.1928. No abstract available.
PubMed 28510665Breddin HK, Hach-Wunderle V, Nakov R, Kakkar VV; CORTES Investigators. Clivarin: Assessment of Regression of Thrombosis, Efficacy, and Safety. Effects of a low-molecular-weight heparin on thrombus regression and recurrent thromboembolism in patients with deep-vein thrombosis. N Engl J Med. 2001 Mar 1;344(9):626-31. doi: 10.1056/NEJM200103013440902.
PubMed 11228276Schulman S, Zondag M, Linkins L, Pasca S, Cheung YW, de Sancho M, Gallus A, Lecumberri R, Molnar S, Ageno W, Le Gal G, Falanga A, Hulegardh E, Ranta S, Kamphuisen P, Debourdeau P, Rigamonti V, Ortel TL, Lee A. Recurrent venous thromboembolism in anticoagulated patients with cancer: management and short-term prognosis. J Thromb Haemost. 2015 Jun;13(6):1010-8. doi: 10.1111/jth.12955. Epub 2015 May 9.
PubMed 25851122Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.
PubMed 19411100Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.
PubMed 18579812Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.
PubMed 27030066EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.
PubMed 21128814EINSTEIN-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 22449293Zhang L, Li M, Zhu Y, Shi Z, Zhang W, Gao B, Li L, Fang Z, Yang G, Han W, Wang L, Yin L, Ke X, Yue J, Gu Z, Liu Z. Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol. BMJ Open. 2021 Oct 25;11(10):e045530. doi: 10.1136/bmjopen-2020-045530.
PubMed 34697109
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04066764
- Acronym / sponsor ID
- EPICT / SAHZhejiangU-002
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism, rivaroxaban, vena cava filters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Huadong Hospital, Shanghai Zhongshan Hospital, Shanghai 5th People's Hospital, Yantai Yuhuangding Hospital, Anhui Provincial Hospital
- Study start
- 8 May 2020 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of new oral anticoagulants and vitamin K antagonists for the anticoagulation for the implantation of vena cava filters in patients with deep venous thrombosis.
Detailed description
Deep vein thrombosis (DVT) of lower extremities is a venous reflux disorder caused by abnormal coagulation of deep vein blood. The main adverse consequences of DVT are pulmonary embolism (PE) and post-thrombotic syndrome, which can significantly affect the quality of life of patients and even lead to death. Anticoagulation is the basic treatment of DVT, which can inhibit the spread of thrombus, facilitate thrombus autolysis and recanalization of the lumen, and reduce the incidence and mortality of PE. For patients with contraindications or complications of anticoagulation therapy, the implantation of inferior vena cava filter may be considered. At the same time, patients with the following conditions may be considered for the implantation of inferior vena cava filter: PE is still present in the case of adequate anticoagulant therapy, floating thrombus in the iliac, femoral or inferior vena cava, thrombectomy is planned for acute DVT, and abdominal, pelvic or lower extremity surgery with high risk factors for PE and acute DVT. The current standard treatment regimen for venous thromboembolism (VTE) anticoagulation is low molecular weight heparin (LMWH) combined with or followed by vitamin K antagonist warfarin. It has been proved that low molecular weight heparin has good safety and effectiveness in the prevention and initial treatment of VTE, especially for VTE prevention and treatment in cancer patients and pregnant patients. As a standard oral anticoagulant, warfarin has definite anticoagulant effect and is cheap. However, low molecular weight heparin needs subcutaneous injection, which can cause adverse reactions such as pain, itching, subcutaneous hemorrhage and nodules at the injection site, and some complications such as heparin-induced thrombocytopenia (HIT). Warfarin anticoagulation therapy requires long-term laboratory monitoring of international standardized ratio (INR) and timely adjustment of warfarin dosage according to INR, which will result in difficult follow-up management, poor compliance, uncertainty of warfarin treatment effect, and even serious bleeding complications. According to relevant studies, the incidence of warfarin-related major bleeding is about 1%-2%, and the recurrence or aggravation of thrombus is also high. Rivaroxaban can simplify treatment, and is safe. It's also not easy to interact with food or drugs. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism, and repeated coagulation monitoring is not required. However, Rivaroxaban lacks sufficient clinical data for perioperative adjuvant anticoagulation therapy of filter implantation. Therefore, this study should be carried out to provide the basis for DVT treatment guidelines and explore the clinical indications of rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanParticipants will receive rivaroxaban 15mg oral twice daily for 3 weeks after operation, later rivaroxaban 20mg oral once daily until 3 months after the filter is retrieved. |
| Warfarin/ Nadroparin | Active comparator | Drug: Warfarin, Drug: NadroparinParticipants will receive Nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 3 months after the filter is retrieved. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.
Key exclusion criteria (14 listed)
- Age < 18 years or age > 75 years,
- With obvious contraindications for anticoagulation therapy,
- Allergic to iodine contrast agents in the past,
- Pregnant or breastfeeding women,
- With malignant tumors and life expectancy < 1 year,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: Xarelto15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral | Drug | Rivaroxaban |
| WarfarinAlso: coumadin3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral | Drug | Warfarin/ Nadroparin |
| NadroparinAlso: FraxiparinDose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous | Drug | Warfarin/ Nadroparin |
Primary outcome
All cause mortality
Time frame: 4 months after the filter is retrieved
Percentage of participants with all deaths
Pulmonary embolism related mortality
Time frame: 4 months after the filter is retrieved
Percentage of Participants with bleeding
Time frame: 4 months after the filter is retrieved
Clinically relevant bleeding is defined as a composite of major or clinically relevant nonmajor bleeding
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism
Time frame: 4 months after the filter is retrieved
the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]
3 secondary outcomes
Percentage of Participants With IVC Filter Retrieval Failure
Time frame: 4 months after the filter is retrieved
Percentage of Participants With an Event for Net Clinical Benefit
Time frame: 4 months after the filter is retrieved
Percentage of Participants With Other Vascular Events
Time frame: 4 months after the filter is retrieved
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 26867832Kearon 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.
- Background: PubMed 28510665Jain A, Cifu AS. Antithrombotic Therapy for Venous Thromboembolic Disease. JAMA. 2017 May 16;317(19):2008-2009. doi: 10.1001/jama.2017.1928. No abstract available.
- Background: PubMed 11228276Breddin HK, Hach-Wunderle V, Nakov R, Kakkar VV; CORTES Investigators. Clivarin: Assessment of Regression of Thrombosis, Efficacy, and Safety. Effects of a low-molecular-weight heparin on thrombus regression and recurrent thromboembolism in patients with deep-vein thrombosis. N Engl J Med. 2001 Mar 1;344(9):626-31. doi: 10.1056/NEJM200103013440902.
- Background: PubMed 25851122Schulman S, Zondag M, Linkins L, Pasca S, Cheung YW, de Sancho M, Gallus A, Lecumberri R, Molnar S, Ageno W, Le Gal G, Falanga A, Hulegardh E, Ranta S, Kamphuisen P, Debourdeau P, Rigamonti V, Ortel TL, Lee A. Recurrent venous thromboembolism in anticoagulated patients with cancer: management and short-term prognosis. J Thromb Haemost. 2015 Jun;13(6):1010-8. doi: 10.1111/jth.12955. Epub 2015 May 9.
- Background: PubMed 19411100Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.
- Background: PubMed 18579812Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.
- Background: PubMed 27030066Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.
- Background: PubMed 21128814EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.
- Background: PubMed 22449293EINSTEIN-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.
- Derived from this study: PubMed 34697109Zhang L, Li M, Zhu Y, Shi Z, Zhang W, Gao B, Li L, Fang Z, Yang G, Han W, Wang L, Yin L, Ke X, Yue J, Gu Z, Liu Z. Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol. BMJ Open. 2021 Oct 25;11(10):e045530. doi: 10.1136/bmjopen-2020-045530.
- Individual participant dataSharing planned: No. Study protocol, statistical analysis plan and informed consent form will be openly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhejie Liu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban, Warfarin and Nadroparin in people with Venous Thromboembolism, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 7 sites 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 14 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li s Yin (86-0571-87913706 ext. 15268135830, lawson4001@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 4 months after the filter is retrieved). The study lists 4 primary outcomes in all. 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 NCT04066764, which also lists 10 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 18 Apr 2024.