Kondratyeva 2010.

Study characteristics
Methods	Study type: open parallel RCT; no blinding Location: Russia, specialist centre Number of centres: 1 Time frame of the study: 2003 to June 2008 Follow‐up: in combined treatment group 58.4 months (median; IQR 0.9; 38.9), in warfarin group follow‐up was 51.6 months (median; IQR 0.9; 48.8)
Participants	Inclusion criteria: people with diagnosis of APS according to 2006 Miyakis criteria (information from the author) Exclusion criteria: severe renal or hepatic insufficiency, severe bleeding in the last 3 months, planning pregnancy in the next year; severe thrombocytopenia < 50000 Total number of participants: 82 randomized and analyzed: 49 into warfarin group and 33 into aspirin and warfarin group (information confirmed with the authors) Characteristics: for warfarin/combined group Mean age: 36.4 (11.2)/40.5 years (SD 11.9) Women: 73%/76% Systemic lupus erythematosus: 56.9%/51.5% Previous events: VTE 65.3%/78.8%; arterial thrombosis 48.9%/54.5%
Interventions	Treatment groups warfarin‐adjusted dose with a target INR 2.0 to 3.0 and aspirin 100 mg/d warfarin‐adjusted dose with a target INR 2.0 to 3.0 Descriptions of treatments and concomitant treatment: NR
Outcomes	Outcomes: recurrence of thrombosis (instrumental verification for thrombotic events: ultrasound duplex scanning of blood vessels; CT of the lungs; clinical symptoms of acute cerebral ischemia confirmed by CT or MRI of the brain; information from the author) TIA (diagnosed by neurologist, transcranial dopplerography of cerebral arteries for changes in neurological status for > 6 hours, CT or MRI in diagnostically unclear cases), hemorrhage major (fatal or life threatening or resulting in lowering of hemoglobin level requiring transfusion or hospitalization), hemorrhage minor (not requiring medical attention, such as nose bleeding, microhematuria, bleeding from the gums, bruising) recorded by the participants in their diaries
Funding source	NR
Notes	The study was published in 2 parts: in the 2007 publication it reported on a total of 60 participants, of whom 50 were randomized (on the basis of the information from the author), while 10 were assigned to warfarin‐only group due to thrombocytopenia or minor bleeding) and in the 2010 publication the study included an additional 32 randomized participants making a total of 82 randomized In the final publication, no information on APS criteria used for diagnosis
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomization ‐ coin tossing ‐ "heads" for monotherapy and "tails" for combination group (information from the author)
Allocation concealment (selection bias)	High risk	Doctor who was tossing coin was aware of group assignment (information from the author)
Blinding of participants and personnel (performance bias) Obj.	Low risk	Objective or objectively verified outcomes: thrombosis and major bleeding: no blinding, outcome unlikely to be influenced by the lack of blinding
Blinding of participants and personnel (performance bias) Subj.	High risk	Self‐reported outcomes: minor bleeding: no blinding, self‐reported outcome, likely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias) Obj.	Low risk	Objective or objectively verified outcomes: thrombosis and major bleeding: no blinding, outcome unlikely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias) Subj.	High risk	Self‐reported outcomes: minor bleeding: no blinding, self‐reported outcome, likely to be influenced by the lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	Additional information obtained from the authors: all patients randomized were analyzed
Selective reporting (reporting bias)	Low risk	No protocol available, but all thrombotic and bleeding outcomes pre‐specified and reported as stated in Methods section of published study
Other bias	Unclear risk	Insufficient information