Portal Vein ThrombosisNCT07602062
Direct Oral Novel Anticoagulants for Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis
A study testing Rivaroxaban in people with Portal Vein Thrombosis and Anticoagulant Therapy, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Vein Thrombosis, Anticoagulant Therapy, Variceal Bleeding
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical and imaging diagnosis of liver cirrhosis and esophagogastric varices, with at least one previous episode of esophagogastric variceal bleeding
- Combined with portal vein thrombosis and D-dimer > 0.8mg/L
- Endoscopic evaluation reveals a high risk of variceal bleeding, and endoscopic treatment is performed to prevent rebleeding of esophagogastric varices
- Signed informed consent form
Who cannot join
- Received other antithrombotic therapies before (including warfarin, aspirin, low-molecular-weight heparin, etc.)
- Combined with hepatocellular carcinoma or other malignancy
- Combined with portal cavernoma
- Combined with severe life-threatening diseases of circulatory, hematological and respiratory system
- Combined with diseases requiring anticoagulant therapy, such as acute portal vein thrombosis, atrial fibrillation, lower extremity venous thrombosis, and pulmonary embolism
- Received TIPS or liver transplantation or splenectomy
- With contraindications to anticoagulant therapy (uncontrollable active bleeding, severe hepatic insufficiency, renal insufficiency, etc.)
- Currently taking immunosuppressive agents, or medications that affect cytochrome P450 (including azole antifungals and protease inhibitors), or strong inducers of CYP3A4 (including rifampicin, phenytoin, carbamazepine, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Dr. Huang xiaoquan
Shanghai
xiaoquan Huang Dr., +86+18801733835, huang.xiaoquan@zs-hospital.sh.cn
About this study
Official title: Multicenter Randomized Controlled Clinical Trial on Direct Oral Novel Anticoagulants for Improving the Prognosis of Cirrhotic Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis
This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.
- Being tested
- Rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban 10mg qd po for 6 months
| Study group | Role | What they receive |
|---|---|---|
| anticoagulant group | Experimental | Rivaroxaban 10mg qd po. for 6 months Receives: Drug: Rivaroxaban |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events at 6 months
Within 6 months, the time from randomization to the first occurrence of any of the following events: including gastrointestinal bleeding, new onset or worsening of ascites > grade II, new onset or worsening of portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, and occurrence of death.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (10)
Adverse events at 1months
Gastrointestinal bleeding, new or aggravated ascites > Grade II, new or aggravated portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, death
Measured: From enrollment to 1months of treatment
Adverse events at 2 months
Gastrointestinal bleeding, new or aggravated ascites > Grade II, new or aggravated portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, death
Measured: From enrollment to the 2 months of treatment
liver function at 6 months of treatment
Changes in liver function at 6 months of treatment measured by ALT/AST/Total Bilirubin level
Measured: From the enrollment to 6 months of treatment
renal function at 6 months of treatment
Changes in renal function at 6 months of treatment measured by serum creatinine level
Measured: From the enrollment to 6 months of treatment
Hemodynamic changes at 6 months
flow velocity of the portal vein system (m/s) measured by ultrasound
Measured: From enrollment to the end of treatment at 6 months
Patency of portal vein thrombosis at 6 months
changes of portal vein thrombosis measured by CT Venography at 6 months (progress or recanalization）
Measured: From enrollment to the end of treatment at 6 months
liver stiffness at 6 months
liver stiffness after 6 months of treatment measured by fibroscan
Measured: From enrollment to the end of treatment at 6 months
spleen stiffness at 6 months
spleen stiffness after 6 months of treatment measured by fibroscan.
Measured: From enrollment to the end of treatment at 6 months
Rivaroxaban Plasma Concentration at 6 Months
Changes in Rivaroxaban Plasma Concentration After 6 Months of Treatment
Measured: From enrollment to the end of treatment at 6 months
Serum metabolomics at 6 months
metabolomic analysis of the patients' serum after treatment for 6 months using Liquid Chromatography-Mass Spectrometry (LC-MS)
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602062
- Sponsor's protocol ID
- KY2026028
- Status last verified
- May 2026
- First submitted
- 25 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Privacy policy
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Clinical Trial on Direct Oral Novel Anticoagulants for Improving the Prognosis of Cirrhotic Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT07602062
- Acronym / sponsor ID
- KY2026028
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (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.
This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anticoagulant group | Experimental | Drug: RivaroxabanRivaroxaban 10mg qd po. for 6 months |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and imaging diagnosis of liver cirrhosis and esophagogastric varices, with at least one previous episode of esophagogastric variceal bleeding
- Combined with portal vein thrombosis and D-dimer > 0.8mg/L
- Endoscopic evaluation reveals a high risk of variceal bleeding, and endoscopic treatment is performed to prevent rebleeding of esophagogastric varices
- Signed informed consent form
Key exclusion criteria (8 listed)
- Received other antithrombotic therapies before (including warfarin, aspirin, low-molecular-weight heparin, etc.)
- Combined with hepatocellular carcinoma or other malignancy
- Combined with portal cavernoma
- Combined with severe life-threatening diseases of circulatory, hematological and respiratory system
- Combined with diseases requiring anticoagulant therapy, such as acute portal vein thrombosis, atrial fibrillation, lower extremity venous thrombosis, and pulmonary embolism
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 |
|---|---|---|
| RivaroxabanRivaroxaban 10mg qd po for 6 months | Drug | anticoagulant group |
Primary outcome
Adverse events at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Within 6 months, the time from randomization to the first occurrence of any of the following events: including gastrointestinal bleeding, new onset or worsening of ascites > grade II, new onset or worsening of portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, and occurrence of death.
10 secondary outcomes
Adverse events at 1months
Time frame: From enrollment to 1months of treatment
Adverse events at 2 months
Time frame: From enrollment to the 2 months of treatment
liver function at 6 months of treatment
Time frame: From the enrollment to 6 months of treatment
renal function at 6 months of treatment
Time frame: From the enrollment to 6 months of treatment
Hemodynamic changes at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Patency of portal vein thrombosis at 6 months
Time frame: From enrollment to the end of treatment at 6 months
liver stiffness at 6 months
Time frame: From enrollment to the end of treatment at 6 months
spleen stiffness at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Rivaroxaban Plasma Concentration at 6 Months
Time frame: From enrollment to the end of treatment at 6 months
Serum metabolomics at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided. Privacy policy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban in people with Portal Vein Thrombosis and Anticoagulant Therapy, run by Shanghai Zhongshan 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyao Chen Prof. (+86+136 0176 7310, chen.shiyao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events at 6 months (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.