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Clinical Trials in China / NCT07602062
Starting soon Not applicable

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

NCT07602062 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2026-06-01
Last updated
2026-05-22

Condition(s) studied

Portal Vein ThrombosisAnticoagulant TherapyVariceal Bleeding

Investigational drug(s) / intervention(s)

Rivaroxaban

Rivaroxaban: Rivaroxaban 10mg qd po for 6 months

Study 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 after endoscopic treatment to prevent rebleeding.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dr. Huang xiaoquan Shanghai China

On this site

📄 Xarelto (rivaroxaban) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07602062 on ClinicalTrials.gov ↗ ← All trials in China