Antiphospholipid Syndrome
Conditions
Keywords
antiphospholipid autoantibodies, antiphospholipid positive
Brief summary
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.
Detailed description
Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years. This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
Interventions
DRUGHydroxychloroquine
Sponsors
AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking
The New York Community Trust
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as: * aCL IgG/M (\>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or * aβ2GPI IgG/M(\>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or * Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations Selected
Exclusion criteria
* History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis * History of Transient Ischemic Attack Confirmed by a Neurologist * SLE Diagnosis based on the ACR Classification Criteria \> 4/11 * Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria * Current Hydroxychloroquine or another antimalarial treatment (-3 months) * Current warfarin treatment (-3 months) * Current heparin therapy( -3 months) * Current pregnancy * History of Hydroxychloroquine eye toxicity * History of Hydroxychloroquine allergy * Known glucose-6-phosphate dehydrogenase deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Acute Thrombosis Event | 2 years | To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment patients randomized to standard treatment will not receive hydroxychloroquine. | 7 |
| Hydroxychloroquine Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.
Hydroxychloroquine | 4 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study closed early | 7 | 4 |
Baseline characteristics
| Characteristic | Hydroxychloroquine | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Age, Continuous | 45.75 years STANDARD_DEVIATION 7.89 | 44 years STANDARD_DEVIATION 8.98 | 44.64 years STANDARD_DEVIATION 8.24 |
| Region of Enrollment United States | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 0 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Primary
Number of Participants With an Acute Thrombosis Event
To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment | Number of Participants With an Acute Thrombosis Event | 0 Participants |
| Hydroxychloroquine | Number of Participants With an Acute Thrombosis Event | 0 Participants |