Abstract | BACKGROUND: METHODS/DESIGN: DESIGN: multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial phase IV trial in secondary and primary care. PARTICIPANTS: 100 participants from 30 UK Stroke Research Network sites who are post- ischemic stroke or intracerebral haemorrhage by three to seven months. Interventions--all patients (1:1): intensive versus guideline blood pressure lowering (target systolic < 125 mmHg versus < 140 mmHg).Interventions-- ischemic stroke (1:1): intensive versus guideline lipid lowering (target low density lipoprotein-cholesterol ( LDL-c) < 1.4 mmol/l versus < 3 mmol/l). HYPOTHESES: PRIMARY OUTCOME: Addenbrooke's Cognitive Examination-Revised. SECONDARY OUTCOMES: feasibility of recruitment and retention of participants, tolerability and safety of the interventions, achieving and maintaining the blood pressure and lipid targets, maintaining differences in systolic blood pressure (> 10 mmHg) and low density lipoprotein-cholesterol (> 1 mmol/l) between the treatment groups, and performing clinic and telephone follow-up of cognition measures. Randomisation: using stratification, minimization and simple randomization. Blinding: participants receive open-label management. Cognition is assessed both unblinded (in clinic) and blinded (by telephone) to treatment. Adjudication of events ( dementia, vascular, serious adverse events) is blinded to management. DISCUSSION: TRIAL REGISTRATION: ISRCTN85562386.
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Authors | Daniel J Blackburn, Kailash Krishnan, Lydia Fox, Clive Ballard, Alistair Burns, Gary A Ford, Jonathan Mant, Peter Passmore, Stuart Pocock, John Reckless, Nikola Sprigg, Rob Stewart, Joanna Wardlaw, Philip M W Bath |
Journal | Trials
(Trials)
Vol. 14
Pg. 401
(Nov 22 2013)
ISSN: 1745-6215 [Electronic] England |
PMID | 24266960
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Blood Pressure
- Clinical Protocols
- Cognition Disorders
(prevention & control)
- Female
- Humans
- Lipids
(blood)
- Male
- Outcome Assessment, Health Care
- Practice Guidelines as Topic
- Prospective Studies
- Sample Size
- Stroke
(complications)
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