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

Arthritis Rheum. 2007 Jul;56(7):2382-91. doi: 10.1002/art.22663.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Antiphospholipid Syndrome / complications*
  • Antiphospholipid Syndrome / drug therapy*
  • Aspirin / therapeutic use*
  • Double-Blind Method
  • Ethnicity
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Selection
  • Placebos
  • Thrombosis / etiology
  • Thrombosis / prevention & control*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Placebos
  • Aspirin