Direct Oral Novel Anticoagulants for Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600128107

Enrollment

Unknown

Registered

2026-07-14

Start date

2026-07-14

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk bleeding from esophageal and gastric varices due to liver cirrhosis with portal vein thrombosis

Interventions

Control Group:None

DOAC Group:Rivaroxaban 10 mg is administered orally once daily, commencing 48 hours following endoscopic therapy.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Ages 18-75 years; 2.Clinically diagnosed with liver cirrhosis with esophageal and gastric varices by image, and has had at least one episode of bleeding from esophageal or gastric varices in the past. 3.Combined with portal vein thrombosis and D-dimer > 0.8 mg/L; 4.High risk of variceal bleeding assessed by endoscopy, and received endoscopic treatment to prevent rebleeding; 5.Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Has already received other antithrombotic treatments (including warfarin, aspirin, low molecular weight heparin, etc.); 2.Combined with hepatocellular carcinoma or other malignant tumors; 3.Combined with portal vein cavernous transformation; 4.Combined with serious life-threatening diseases such as circulatory, blood, or respiratory system disorders; 5.Combined with acute portal vein thrombosis, atrial fibrillation, lower limb venous thrombosis, pulmonary embolism, and other conditions that require anticoagulant treatment; 6.Previously underwent TIPS intervention, liver transplant, or spleen removal surgery; 7.Combined with contraindications for anticoagulant therapy (uncontrollable active bleeding, severe liver dysfunction, kidney problems, etc.); 8.Patients taking immunosuppressants, or drugs that affect cytochrome P450 (including azole antifungals and protease inhibitors), or strong CYP3A4 inducers (including rifampin, phenytoin, and carbamazepine).

Design outcomes

Primary

Measure	Time frame
Adverse Events;	—

Secondary

Measure	Time frame
Status of portal vein thrombosis;Rivaroxaban blood concentration;Liver and kidney function after treatment;Liver stiffness and spleen stiffness;Portal vein hemodynamics;Plasma metabolomics;	—

Countries

China

Contacts

Public ContactChen Shiyao

Zhongshan Hospital, Fudan University

chen.shiyao@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026