Top 10 Series: APS ACTION International Clinical Database and Repository

Top Ten Points that Antiphospholipid Antibody-positive Patients Should Know About APS ACTION International Clinical Database and Repository

Christine Marchello
Volunteer, APS ACTION


Doruk Erkan, MD

Associate Attending Rheumatologist, Hospital for Special Surgery
Associate Professor of Medicine, Weill Cornell Medical College
Associate Physician-Scientist, Barbara Volcker Center for Women and Rheumatic Disease

1. What is Antiphospholipid Syndrome (APS)?

Antiphospholipid syndrome (APS) is a systemic autoimmune disorder in which the patient’s immune system makes antibodies (antiphospholipid antibodies [aPL]) that increase the risk of blood clots (thickened blood) and pregnancy complications, including miscarriages. Other clinical problems related to aPL include livedo reticularis (a lacey purple pattern on the skin), heart valve disease, low platelet count, anemia, and kidney disease.

2. What is APS ACTION?

APS ACTION - Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking - is an international research network focused on conducting clinical research studies with a commitment to prevent, treat, and cure aPL-associated symptoms.

The network was created in November 2010 by 25 international physician scientists; currently there are 40 members from 28 centers worldwide, including Hospital for Special Surgery. Learn more about the APS ACTION research network.

3. What is a research registry and what is APS ACTION International Clinical Database and Repository (registry)?

A research registry is a collection of information about patients who have a particular disease or condition. Investigators maintain this information for use in future research studies.

The APS ACTION International Clinical Database and Repository registry is a multi-center collaborative effort to design and maintain a secure, web-based clinical database of persistently aPL-positive patients so that the natural course of these patients can be followed over the next 10 years.

Conclusions drawn from the data will be more reliable than if they were based on data collected from only a few people in a study in a limited location. The registry is not only large, but it is composed of a collaborative effort from multiple countries. This kind of communication and sharing of information allows for the potential of expedited research.

The APS ACTION Registry is taking place in the United States, Canada, Europe, South America, Asia, and Australia. We expect to include 200 patients at Hospital for Special Surgery and a total of 2000 patients around the world.

4. Why is the APS ACTION registry important?

Much remains to be learned about the cause, full range of symptoms, diagnosis, and treatment for APS. Information gathered through the APS ACTION registry facilitates a better assessment of aPL-related clinical problems and helps determine the optimal management of aPL-positive patients.

5. What are the benefits of participating in the registry?

By participating in this registry, you can be a part of a groundbreaking effort to uncover new information about APS, its causes and treatment. In addition:

  • You can be informed of other research studies conducted by HSS that you may be interested in participating in (all future research studies based on the information in this registry will be subject to oversight by APS ACTION Executive Committee and Hospital for Special Surgery’s Institutional Review Board).
  • You will receive standard cardiovascular disease and blood clot prevention counseling for special situations (e.g., long flights, surgery).
  • You will be offered genetic testing (i.e. blood tests) that is specific to APS.

6. What does participation in the registry involve?

Your participation will involve a total of 11 study visits and 10 telephone interviews over a period of 10 years. Annual study visits are expected to last 20-30 minutes and can take place at the time of your routine visits to Hospital for Special Surgery. No additional visits are required unless you develop new aPL-related clinical events such as blood clots or pregnancy losses.

At each visit, 20-50ml (4-10 teaspoons) of blood will be drawn and information will be taken. This is done by collecting medical history, physical exam findings, and laboratory tests; storing the information in a database; and using that information at a later time for research studies. For example, information in this registry may be used in a future study to evaluate thrombosis prevention in aPL-positive patients with no history of thrombosis.

There is no cost to you for your participation. Your decision to take part in this registry is completely voluntary. You will sign a consent form when you enroll, and you may withdraw from the registry at any time.

7. Am I Eligible for the Registry?

You are eligible if your blood test is persistently positive for at least one aPL test. These include:

  • Lupus Anticoagulant (LA) Test
  • Anticardiolipin Antibody (aCL)
  • Anti-ß2-Glycoprotein-I Antibody (aß2GPI)

8. Who will be accessing my information?

Hospital for Special Surgery investigators in this study are Dr. Doruk Erkan (principal investigator), Dr. Jane Salmon (co-investigator), Dr. Michael Lockshin (co-investigator), JoAnn Vega (Study Coordinator) and Glendalee Ramón (Study Coordinator).

APS ACTION investigators at the other participating centers may be able to access your data for future research. However, Hospital for Special Surgery investigators will remove any personal identification (including the patient’s name) from the information stored in the registry and will store the blood samples in a separate, secure location. Thus, your personal information will be kept private and APS ACTION investigators will be granted access only to data that are no longer identifiable.

9. Are there other ongoing APS ACTION projects in addition to the registry?

APS ACTION is also conducting a clinical study of the benefits of hydroxychloroquine in the reduction of blood clot formation in patients with positive aPL; the number of studies are expected to increase in the near future. For more information on ongoing clinical studies, visit the APS ACTION webpage and see “Research”.

10. How do I become involved?

For more information on the APS ACTION Registry and/or to participate in the registry, please contact the Study Coordinator, or ask your doctor to do so for you.

Contact Information:
JoAnn Vega, CRCC
Hospital for Special Surgery Research Coordinator
APS ACTION Lead Coordinator
Tel: 212.774.2795
Fax: 212.774.7298
Email: vegaj@hss.edu
www.apsaction.org


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