| Methods |
R = blocked and stratified randomisation, telephone to central randomisation system
Study treatment was not blinded
ITT
Follow up: not available for 32 (15 Rx, 17 control) either by withdrawal of consent or loss to FU |
| Participants |
International
994 men, 768 women, mean age 66 years
100% CT or MRI before entry
Ischaemic stroke and unable to walk unassisted
< 48 hours since stroke onset
NIHSS score 2 or more |
| Interventions |
Rx: enoxaparin 40 mg sc once daily
Control: heparin sc (5000 IU 12‐hourly)
Duration: 10 days (range 6 to 14) |
| Outcomes |
Death
DVT (systematic venography or ultrasound if venography not possible)
PE (symptomatic)
Extracranial haemorrhage
Intracranial haemorrhage (systematic CT)
Modified Rankin Scale |
| Notes |
Ex: specified by protocol
FU: 90 days
Sponsored by Sanofi‐Aventis (Paris, France) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The sponsor generated the randomisation schedule in permuted blocks of 4, stratified by baseline stroke severity that was implemented centrally by an independent interactive voice‐response system |
| Allocation concealment (selection bias) |
Low risk |
The randomisation schedule was implemented centrally by an independent interactive voice‐response system |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not blinded, but all major outcome events were reviewed blind to treatment allocation by an adjudication committee |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Primary outcome data not available for 32 participants, number with missing modified Rankin Scale status not stated |
| Selective reporting (reporting bias) |
Low risk |
Trial registered NCT00077805, protocol‐specified outcomes all reported |
