Could your genes raise your risk for blood clots and miscarriages?
NCT ID NCT00482794
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks for inherited genes that may increase the risk of developing antiphospholipid antibody syndrome (APS), a condition that causes abnormal blood clotting, leading to problems like strokes, heart attacks, and miscarriages. Researchers will recruit 2,800 people with APS and their family members to collect blood samples and medical histories. The goal is to identify genetic risk factors, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,800 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jun 2006
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals with antiphospholipid antibody syndrome and their family members
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common antiplatelet drug replace warfarin after APS-Related stroke?
- A blood test that could predict clots in autoimmune disease?
- Blood platelet trends may reveal hidden risk in autoimmune disease
- Immune clues in the blood may foretell heart trouble
- Can a simple blood test tell two forms of a clotting disorder apart?
- New fingerstick test for blood thinner monitoring put to the test