Thrombotic antiphospholipid syndrome
Conditions
Interventions
Treatment group: Zhengqing Fengtongning + warfarin/rivaroxaban
Control group:warfarin/rivaroxaban
Sponsors
The People's Hospital of Yubei District of Chongqing Affiliation of the Leader
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who concurrently meet the diagnostic criteria for thrombotic antiphospholipid syndrome as defined by both the 2006 Sydney classification criteria and the revised 2023 APS classification criteria, aged between 18 and 75 years, and who provide written informed consent will be enrolled.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they meet any of the following criteria: (1) concurrent active phase of other autoimmune diseases; (2) severe hepatic or renal insufficiency; (3) pregnancy; (4) history of major bleeding in the recent period; or (5) inability to adhere to the medication regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombotic recurrence rate;death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thrombotic recurrence rate;Coagulation Index (fibrinogen, international normalized ratio, activated partial thromboplastin time, D-dimer);Inflammatory Cytokine Spectrum (IL-6, TNF-a);Antiphospholipid Antibodies level (anti cardiolipin antibodies, anti - ß 2 glycoprotein 1, lupus anticoagulant);Endothelial activation (TF, VEGF, VCAM-1, ICAM-1);immune cell subsets;Adverse Reactions rate (rash, gastrointestinal discomfort, etc.); | — |
Countries
China
Contacts
Public ContactLiang Luo
The People's Hospital of Yubei District of Chongqing
Outcome results
None listed