Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks

Recruiting

• Conditions: Anti Phospholipid Syndrome

• Registration Number: NCT05230017
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and pregnancy morbidity in patients with persistently positive antiphospholipid antibodies (aPLs). However, large-scale research on general population with persistent aPLs has been lacking. This project proposes to establish the first multicenter cohort of patients with persistently positive aPLs in China and conduct a comprehensive clinical phenotyping study. Based on traditional phenotypes of thrombotic and pregnancy events, the focus will be on extra-standard clinical phenotypes and prospective assessment of event risk and prognosis in aPL-positive population. A prospective analysis of extra-standard antibodies will also be conducted to recommend detection criteria for extra-standard antibody application in China and to assess their clinical significance.

Detailed Description

Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks (CAPSTONE) is a national research network created to register patients with persistent aPLs. We aim at enrolling 2000 patients from a total of six centers, lead by the Peking Union Medical College Hospital (PUMCH). The aPLs assay will be validated in the central lab in PUMCH. All patients will be followed every six months, and up to three years. Thrombotic and pregnancy events related to aPLs will be recorded, as well as extra-criteria clinical phenotypes.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Study Start: 2022-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• The presence of one or more of the antiphospholipid antibodies (aPL) tested according to the 2006 Sapporo APS clasification criteria, on two or more occasions at least 12 weeks apart:

Exclusion Criteria

• Patients refuse to participate;
• Unable to be followed.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular thrombosis related to aPLs	36 months	Venous thrombosis, arterial thrombosis, microscopic thrombosis
Pregnancy morbidity related to aPLs	36 months	One or more unexplained deaths of a morphologically normal fetus at ≥10 weeks gestation, or one or more premature births of a morphologically normal neonate before 34 weeks gestation because of eclampsia, preeclampsia, or placental insufficiency, or three or more consecutive spontaneous pregnancy losses at \<10 weeks gestation, unexplained by chromosomal abnormalities or by maternal anatomic or hormonal causes.

Secondary Outcome Measures

Name	Time	Method
antiphospholipid antibody profile	36 months	IgG and/or IgM anticardiolipin (ACL) antibodies, IgG and/or IgM anti-beta2-glycoprotein (GP), Lupus anticoagulant (LA) activity, IgA ACL/anti-β2-GP I，anti-annexin 5 antibody, anti-protein C, anti-protein S, anti-vimentin/cardiolipin complex, and anti-lysobisphosphatidic acid (LBPA) et al.
Extra-criteria manifestations	36 months	Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)

Trial Locations

Locations (18)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Shunyi Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

The Second People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

The Affilicated Hospital of Inner Mongolia Medical University; 🇨🇳 Hohhot, Inner Mongolia, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The Second Affiliated Hospical of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

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