Table 3: Details of clinical studies investigating optimal management of aPL carriers.

Author, year [Ref]Type of study patientsInclusion criteriaTreatmentObservation timeEvent RateMain findings

Erkan et al., 2001 [49]Retrospective65aPL+ women with 1 foetal lossLDASA 
No treatment
Mean 8.1 years10% 
59%
LDASA beneficial in aPL+ women with 1 foetal loss

Erkan et al., 2002 [50]Cross-sectional56aPL+ asymptomatic subjectsLDASA/HCQ6 months0LDASA/HCQ beneficial in asymptomatic aPL+ individuals

Girón-González et al., 2004 [41]Prospective178aPL+ asymptomatic subjectsLMWH/LDASA prophylaxis during high-risk situation3 years0LMWH/LDASA prophylaxis during high-risk situation beneficial as primary prophylaxis in aPL carriers

Mok et al., 2005 [51]Retrospective272SLE patients (aPL+ 29%)HCQ 
No HCQ
27 years1.26/100 patient-yearsPatients taking HCQ had fewer thrombotic complications than those who were not (OR 0.17, 95% CI 0.07–0.44; )

Tarr et al., 2007 [52]Prospective81aPL+ SLE patientsLDASA 
None
5 years1.9% 
6.9%
LDASA/HCQ beneficial in asymptomatic aPL+ SLE patients

Erkan et al., 2007 [53]Randomized, controlled98aPL positive subjectsLDASA 
No treatment
Mean 2.46 ± 0.76 years2.75/100 patient-years 0/100 patient-yearsLDASA not beneficial in the primary prophylaxis of aPL positive carriers

Tektonidou et al., 2009 [12]Prospective288144 aPL+ SLE patients 
144 aPL− SLE patients
LDASA/HCQ104 months 
112 months
20.1% 
7.6%
LDASA and HCQ protective against thrombosis in SLE patients

Cuadrado et al., 2014 [54]RCT166aPL+ patientsLDASA 
LDASA + low intensity warfarin
5 years4.9% 
 4.8%
LDASA and LDASA + warfarin were equally effective, but lower bleeding risk with LDASA only