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. 2020 Oct 12;2020(10):CD012169. doi: 10.1002/14651858.CD012169.pub3

Yamazaki 2009.

Study characteristics
Methods Study type: parallel RCT
Location: Japan
Number of centres: 1
Time frame of the study: NR
Follow‐up: 3 years
Funding: Ministry of Health, Japan
Participants Inclusion criteria: people with APS and history of stroke
Exclusion criteria: NR
Total number of participants: 60 participants randomized, 60 analyzed: 20 in aspirin alone group; 20 in aspirin + cilostazol group; 20 in aspirin + warfarin group
Characteristics
Age: NR
Sex: NR
Systemic lupus erythematosus: NR
Previous events: NR
Cardiovascular risk factors: NR
Antibodies present: NR
Interventions Treatment groups
  • 100 mg/d aspirin alone group

  • 100 mg/d aspirin + cilostazol 100 mg twice daily

  • 100 mg/d aspirin + warfarin (INR 2.0 to 2.5) group


Descriptions of treatments and concomitant treatment: NR
Outcomes Primary outcomes: recurrence of stroke based on brain MRI
Secondary outcomes: NR
Funding source NR
Notes All 3 groups were planned to be followed up for 3 years; however; group treated with 100 mg/d aspirin alone was discontinued after a year for "humanitarian" reasons; several attempts to contact the authors for additional information were unsuccessful.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details apart from "patients were randomly treated"
Allocation concealment (selection bias) Unclear risk Insufficient information provided
Blinding of participants and personnel (performance bias)
Obj. Unclear risk Insufficient information provided
Blinding of outcome assessment (detection bias)
Obj. Unclear risk Insufficient information provided
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to judge if all outcome data reported
Selective reporting (reporting bias) Unclear risk Insufficient information provided
Other bias High risk All 3 groups were planned to be followed up for 3 years; however; group treated with 100 mg/d aspirin alone was discontinued after a year for "humanitarian" reasons

AC: anticoagulant; AF: atrial fibrillation; AP: antiplatelet; APS: antiphospholipid syndrome; BMI: body mass index; CI: confidence interval;CT: computed tomography; DVT: deep vein thrombosis; INR: international normalized ratio; ITT: intention‐to‐treat; LA: lupus anticoagulant; MI: myocardial infarction; MRI: magnetic resonance imaging; NR: not reported; PE: pulmonary embolism; PP: per protocol; RCT: randomized controlled trial; SAE: serious adverse events; SD: standard deviation; TIA: transient ischemic attack; VKA: vitamin K antagonists; VTE: venous thromboembolism.