Recruiting

Genetic Risk Factors

Sponsor:

Duke University

Code:

NCT00482794

Conditions

Antiphospholipid Syndrome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid antibodies, which are proteins in the blood that interfere with the body's ability to perform normal blood clotting. Clinical problems associated with antiphospholipid antibodies include an increased risk for the formation of blood clots in the lungs or deep veins of the legs, stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS have a genetic predisposition for developing the syndrome. This study will use a genetic strategy to identify potential inherited risk factors for the development of APS by recruiting people with APS who have family members also affected by the syndrome or by another autoimmune disorder, such as lupus or rheumatoid arthritis.

Conditions

Antiphospholipid Syndrome

Study ID

NCT00482794

Start date

Jun, 2006

Status verified date

May, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Persistent presence of an antiphospholipid antibody, as defined by one or both of the following criteria:

1. Medium or high anticardiolipin antibody level in the blood on two or more occasions at least 6 weeks apart
2. Presence of lupus anticoagulant in the plasma on two or more occasions at least 6 weeks apart
  • Presence of clinical symptoms seen in patients with APS, including vascular thrombosis (one or more clinical episodes of arterial, venous, or small vessel thrombosis in any tissue or organ) and/or pregnancy morbidity, defined as any of the following:

1. One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetus morphology documented by ultrasound or direct examination or the fetus
2. One or more premature births of a morphologically normal baby at or before the 34th week of gestation because of severe pre-eclampsia, eclampsia, or severe placental insufficiency
3. Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded
  • People who have elevated antiphospholipid antibody levels but do not fully meet clinical criteria for APS, and do have affected family members, will be considered for enrollment

Exclusion Criteria:

  • No documented presence of antiphospholipid antibody

Study Design

Enrollment

2800 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Individuals with APS who also have one or more of their family members affected specifically by APS

2

Individuals with APS who also have one or more of their family members affected by another type of autoimmune disorder, such as lupus or rheumatoid arthritis.

3

Individuals with APS and no family or no family affected with APS or another autoimmune disorder

Primary outcome measure

  • characterize genetic risk factors associated with the development of familial antiphospholipid antibody syndrome. [ Time Frame: duration of the study ]

Central Contacts and Locations

Central contacts

Thomas L. Ortel, MD, PhD

919-684-5350thomas.ortel@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Thomas L. Ortel, MD, PhD

More Information

Sponsor

Duke University

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Antiphospholipid Antibody Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-29.