The DOI matches its Crossref record; 46 of the 46 references it cites were found in a registry or an index.
Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: a randomized, double-blind, placebo controlled trial in asymptomatic antiphospholipid antibody-positive individuals.
Abstract
OBJECTIVE: To determine the efficacy of a daily dose of 81 mg aspirin in primary thrombosis prevention in asymptomatic, persistently antiphospholipid antibody (aPL)-positive individuals (those with positive aPL but no vascular and/or pregnancy events). METHODS: The Antiphospholipid Antibody Acetylsalicylic Acid (APLASA) study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in which asymptomatic, persistently aPL-positive individuals were randomized to receive a daily dose of 81 mg of aspirin or placebo. In a separate observational and parallel study, asymptomatic, persistently aPL-positive individuals who were taking aspirin or declined randomization were followed up prospectively. RESULTS: In the APLASA study, 98 individuals were randomized to receive aspirin or placebo (mean +/- SD followup period 2.30 +/- 0.95 years), of whom 48 received aspirin and 50 received placebo. In the observational study, 74 nonrandomized individuals were followed up prospectively (mean +/- SD followup period 2.46 +/- 0.76 years); 61 received aspirin and 13 did not. In the APLASA study, the acute thrombosis incidence rates were 2.75 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for the placebo-treated subjects (hazard ratio 1.04, 95% confidence interval 0.69-1.56) (P = 0.83). Similarly, in the observational study, the acute thrombosis incidence rates were 2.70 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for those not treated with aspirin. All but 1 patient with thrombosis in either study had concomitant thrombosis risk factors and/or systemic autoimmune disease at the time of thrombosis. CONCLUSION: Our results suggest that asymptomatic, persistently aPL-positive individuals do not benefit from low-dose aspirin for primary thrombosis prophylaxis, have a low overall annual incidence rate of acute thrombosis, and develop vascular events when additional thrombosis risk factors are present.
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“The study was terminated earlier for low rate of events and showed that in patients with persistently positive aPL, aspirin was no more effective than placebo.”
From Incidence of a first thromboembolic event in asymptomatic carriers of high-risk antiphospholipid antibody profile: a multicenter prospective study (2011) · cites this paper as [17]
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Meschia, J. F., Bushnell, C., Boden-Albala, B., Braun, L. T., Bravata, D. M., Chaturvedi, S., Creager, M. A., Eckel, R. H., Elkind, M. S. V., Fornage, M., et al. (2014) · Stroke · doi:10.1161/str.0000000000000046 · Cited by 2,650
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Metadata
- Authors
- Erkan, D., Harrison, M. J., Levy, R., Peterson, M., Petri, M., Sammaritano, L., Unalp‐Arida, A., Vilela, V., Yazici, Y., & Lockshin, M. D.
- Affiliations
- Hospital for Special Surgery (US)
- Hospital Universitário Pedro Ernesto (BR)
- Johns Hopkins University (US)
- Venue
- Arthritis & Rheumatism
- Publisher
- Wiley
- Published
- 2007-06-28
- Volume
- 56
- Issue
- 7
- Pages
- 2382-2391
- ISSN
- 0004-3591 (ISSN-L)
- 1529-0131
- OpenAlex
- W2068492012
- Cited by
- 401
- References
- 46
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 12 · 2023: 16 · 2022: 10 · 2021: 16 · 2020: 16 · 2019: 18 · 2018: 19 · 2017: 23 · 2016: 24 · 2015: 16 · 2014: 27 · 2013: 32 · 2012: 37
- FWCI
- 21.25
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Arthritis & Rheumatism (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- aspirin, antiphospholipid syndrome, antiphospholipid antibodies, thromboprophylaxis, low-dose aspirin, thrombosis risk factors, vascular events
- MeSH terms
- Adult, Anti-Inflammatory Agents, Non-Steroidal, Aspirin, Double-Blind Method, Ethnicity, Female, Humans, Male, Middle Aged, Placebos, Thrombosis, Antiphospholipid Syndrome, Patient Selection
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