Cited by 401Systemic Lupus Erythematosus ResearchBlood Coagulation and Thrombosis MechanismsVenous Thromboembolism Diagnosis and Management

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Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: a randomized, double-blind, placebo controlled trial in asymptomatic antiphospholipid antibody-positive individuals.

Erkan, Doruk, Harrison, Melanie J., Levy, Roger, Peterson, Margaret, Petri, Michelle, Sammaritano, Lisa, Unalp‐Arida, Aynur, Vilela, Veronica, Yazici, Yusuf, Lockshin, Michael D.·2007·Arthritis & Rheumatism

DOI 10.1002/art.22663

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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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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)
ORCID: Erkan, Doruk
Levy, Roger
Petri, Michelle
Sammaritano, Lisa
Lockshin, Michael D.
Venue: Arthritis & Rheumatism
Publisher: Wiley
Published: 2007-06-28
Volume: 56
Issue: 7
Pages: 2382-2391
ISSN: 0004-3591 (ISSN-L)
1529-0131
DOI: 10.1002/art.22663
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
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
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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Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: a randomized, double-blind, placebo controlled trial in asymptomatic antiphospholipid antibody-positive individuals.

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