Effectiveness and Safety of Rivaroxaban Used in Extended Anticoagulation for Pulmonary Embolism Patients

Effectiveness and Safety of Rivaroxaban Used in Clinical Practice of Extended Anticoagulation for Pulmonary Embolism Patients in China, XAPEC-EXT

Domestic and international guidelines for the management of pulmonary embolism have suggested that the standard duration of anticoagulation should cover at least 3 months.Whether extended anticogulation therapy shoud balance the efficacy and safety of the therapy.Nevertheless, the concerning about bleeding may affect the decision on the extended anticoagulation for pulmonary embolism patients who may benefit from continuing anticoagulation. Rivaroxaban is an oral direct factor Xa inhibitor, it does not require routine laboratory monitoring and has no food interactions and only a few drug interactions compared to standard of care with the recommendation for the treatment of pulmonary embolism by several guidelines.Our study aims to acquire the data of effectiveness and safety of rivaroxaban used in clinical practice of extended anticoagulation for pulmonary embolism patients in China through this perspective observational study.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: Rivaroxaban

Detailed Description

This is a perspective, multicenter, single-arm, non-interventional, and observational study. The primary objective is to evaluate the effectiveness and safety of rivaroxaban used in extended treatment of pulmonary embolism in a real-world.The secondary objective aims to analyze the drug usage pattern of rivaroxaban, patient satisfaction and medical resource utilization used in extended treatment of pulmonary embolism in a real-world.496 subjects will be enrolled in this study. The primary outcome of this study is net clinical benefit.

All patients with rivaroxaban should be followed up to 12 months, or about 30 days after the end of rivaroxaban treatment if discontinued before the completion of 12 months. Follow up visits occur at initial visit, 3, 6, 9, 12 months after the initial visit, where such data have been collected as part of routine clinical practice, by phone and or face to face interview.

During each follow up visit, the date of visit, physical examination, ACTS and, as applicable, changes in the concomitant medication, changes in concomitant disease,changes in pulmonary embolism and/or treatment regimen, new diagnosis of venous thromboembolism, medical resources utilization, and adverse events will be obtained and recorded.

Starting with the first application of rivaroxaban after enrollment into the study or follow-up period, all AEs would be documented. For each AE, the investigator must assess and document the seriousness, duration, relationship to product, action taken and outcome of the event.

• Study Type: Observational
• Enrollment (Anticipated): 496

Contacts and Locations

• Study Contact: Name: Zhenguo Zhai, Ph.D; Phone Number: zhaizhenguo2011@126.com; Email: zhaizhenguo2011@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pulmonary Embolism patients

Description

Inclusion Criteria:

1. Male or female adults aged 18 years or above
2. Objectively confirmed diagnosis of symptomatic or asymptomatic pulmonary embolism
3. Already received 6 to 12 months anticoagulant
4. Indication for extend anticoagulant for at least 3 months with rivaroxaban( as assessed by the investigator)5)Written informed consent

Exclusion Criteria:

1. Patients with another indication for anticoagulation other than venous thromboembolism.
2. Patients with contraindications listed in rivaroxaban label in china.
3. Patients who participated in another study within 30 days
4. Life expectation less than 3 months

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net clinical benefit	Net clinical benefit(the composite of major bleeding and symptomatic recurrent venous thromboembolism)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality	12 months
The symptomatic recurrent venous thromboembolism	The symptomatic recurrent venous thromboembolism, is the composite of recurrent deep vein thrombosis or fatal or non-fatal pulmonary embolism.	12 months
Major bleeding	Major bleeding was defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.	12 months
Clinical related non-major bleeding events	Clinical related non-major bleeding events: other dominant bleeding, which does not conform to the criteria for major bleeding, but requires medical intervention; an unscheduled contact with a doctor either through telephone or through face-to-face interview, temporary stop of the treatment, or other discomforts, such as pain.	12 months
The satisfaction with anticoagulant treatment	The Anti-Clot Treatment Scale (ACTS) is a 17-item patient-reported instrument of satisfaction with anticoagulant treatment.	12 months
Length of stay in hospital	Medical resources utilization	12 months
The number of outpatient visits	Medical resources utilization	12 months
Medical costs due to bleeding or embolism	Medical resources utilization	12 months
Drug use patterns	Drug use patterns (including dosage of rivaroxaban, course of treatment, reasons for withdrawal/interruption/dressing change, combined medication)	12 months
Adverse events	Adverse events (AEs) and serious adverse drug reactions	12 months

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Zhenguo Zhai, Ph.D, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 30, 2020
• Primary Completion (ANTICIPATED): November 29, 2022
• Study Completion (ANTICIPATED): May 30, 2024

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Clinical Practice of Extended Anticoagulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: CJFH-2020-PE-ZZG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No