Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks

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.

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Key information

Conditions

Anti Phospholipid Syndrome Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Shunyi Hospital, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Vascular thrombosis related to aPLs

Time frame: 36 months

Venous thrombosis, arterial thrombosis, microscopic thrombosis
Pregnancy morbidity related to aPLs

Time frame: 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 outcomes

antiphospholipid antibody profile

Time frame: 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

Time frame: 36 months

Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)

Study contacts

Contact information is provided by the study sponsor or research team.

Jiuliang Zhao, M.D.

CONTACT

[email protected]

0086-13810103105

Yangzhong Zhou, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Acronym: CAPSTONE

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Feb 8, 2022
Registry last updated: Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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