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 |
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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 |
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Interventions |
Treatment groups
Descriptions of treatments and concomitant treatment: NR |
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Outcomes |
Primary outcomes: recurrence of stroke based on brain MRI Secondary outcomes: NR |
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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.