Pergola 2014.
| Study characteristics | ||
| Methods | RCT Unit of randomisation: participant |
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| Participants | Place of recruitment: not documented Numbers randomised: total: 3020 (I: 1501; C: 1519) % Completing final follow‐up: 98% Inclusion criteria: lacunar stroke syndrome confirmed by MRI, > 30 years old, normotensive and hypertensive patients Exclusion criteria: no surgical amenable ipsilateral carotid artery disease, no major risk cardio‐embolic sources Type of stroke (%): small subcortical stroke (100%) Mean age: 63 +/‐ 11 years Gender (men): 63% Ethnicity: white (51%), Hispanic (30%), black 916%) Socio‐economic or socio‐demographic status: USA (56%), Latin America (23%), Spain (12%) Canada (9%) |
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| Interventions | Intervention details (components, length, frequency): participants were randomised to 1 or 2 levels of BP control either 'intensive' (< 130 mmHg) or 'usual' (130–149 mmHg). Also participants were randomly assigned to take clopidogrel 75 mg daily or the matching placebo Location: outpatient clinic Mode of delivery: outpatient clinic face to face, free prescriptions were given Personnel responsible for delivery: physicians Timing post‐stroke: 6 months or less Control: usual care ‐ including standard (< 140 mmHg) blood pressure control |
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| Outcomes | 3 years: time to first stroke relapse; stroke relapse rate; proportion of participants meeting targets for blood pressure, blood fats, blood sugar and BMI | |
| General Information | Funding: this research was funded by the National Institute of Neurological Disorders and Stroke (NINDS # 2 U01 NS38529‐04A1)
Country of origin: USA Publication language: English |
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| Notes | Analysis method: analysis of variance Risk of bias: unclear |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised using a 2 x 2 factorial design stratified by clinical centre and baseline hypertensive stats. Data was inputted and a computer generated unique number was given to assign participants |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not addressed |
| Selective reporting (reporting bias) | Low risk | Study protocol is available in a previous publication |
| Other bias | Low risk | The study appears to be free of other sources of bias |