Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

NCT06194617 | Recruiting DMC FDA Drug

• 1 other identifier: PUMCH-Rivaroxaban in Elderly
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.

Conditions

Pulmonary Embolism; Venous Thromboembolism; Anticoagulant-induced Bleeding

Keywords

Pulmonary Embolism; Venous Thromboembolism; Direct Oral Anticoagulants

Outcome Measures

Primary Outcomes (3)

• Symptomatic recurrence of VTE.

  Recurrent VTE.

  through study completion, an average of 1 year

• Fatal or non-fatal PTE.

  Recurrent VTE.

  through study completion, an average of 1 year

• Major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events as defined by the International Society on Thrombosis and Haemostasis (ISTH).

  Bleeding Events

  through study completion, an average of 1 year

Study Arms (1)

Patients with pulmonary embolism and using direct oral anticoagulants

Patients with pulmonary embolism and using direct oral anticoagulants

Drug: Direct oral anticoagulant

Interventions

Direct oral anticoagulant DRUG

Patients take DOACs according to their condition, with the dosage determined by the clinical physician.

Patients with pulmonary embolism and using direct oral anticoagulants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with objectively diagnosed acute symptomatic pulmonary embolism (with or without concurrent deep vein thrombosis) by imaging, who have completed acute anticoagulation and entered the anticoagulation maintenance phase。

You may qualify if:

• (1) Adult patients with objectively diagnosed acute symptomatic pulmonary embolism (with or without concurrent deep vein thrombosis) by imaging, who have completed acute anticoagulation and entered the anticoagulation maintenance phase; (2) Life expectancy greater than 3 months; (3) Meeting the indications for Xa factor inhibitor use; (4) Willingness to participate in this study, sign the informed consent form, and adhere to regular follow-ups.

You may not qualify if:

• (1) Moderate or severe hepatic impairment (Child-Pugh Class B or C); (2) Severe renal impairment (CrCl \< 15ml/min); (3) Pregnant or breastfeeding women; (4) Spontaneous bleeding tendencies, such as coagulation disorders or low platelet count (PLT \< 20×10\^9/L); (5) Contraindications to other Xa factor inhibitors' usage; (6) Patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood and Urine.

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Central Study Contacts

juhong Shi, M.D

CONTACT

+8513701178492; shijh@pumch.cn

min Peng, M.D

CONTACT

+8618510797366; pengmin@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: April 1, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 8, 2024

Record last verified: 2023-12

Locations

CN (1)