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Randomised controlled trial of a Calcium Channel or Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker Regime to Reduce Blood Pressure Variability following Ischaemic Stroke (CAARBS): a protocol for a feasibility study

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Abstract

Introduction: Raised blood pressure (BP) is common post-stroke and is associated with a poor prognosis, yet trials of BP lowering in the immediate post-stroke period have not demonstrated a benefit. One possible explanation for this may be that BP variability (BPV) rather than absolute levels predicts outcome, as BPV is increased post-stroke and is associated with poor outcomes. Furthermore, there is evidence of distinct antihypertensive class effects on BPV despite similar BP lowering effects. However, whether BPV in the immediate post-stroke period is a therapeutic target has not been prospectively investigated.

The objectives of this trial are to assess the feasibility and safety of recruiting patients following an acute ischaemic stroke or transient ischaemic attack (TIA) to an interventional randomised controlled trial comparing the effects of two different antihypertensive drug classes on BPV. Secondary exploratory objectives are to assess if different therapeutic strategies have diverse effects on levels of BPV and if this has an impact on outcomes.

Methods: 150 adult patients with first-ever ischaemic stroke or TIA who require antihypertensive therapy for secondary prevention will be recruited within 72 hours of the event from stroke services across three sites. After baseline assessments they will be randomly assigned to treatment with a calcium channel blocker or angiotensin converting enzyme inhibitor/angiotensin receptor blocker based regimen and followed-up for a period of three months.

Ethics and dissemination: Ethical and regulatory approvals have been granted. Dissemination is planned via publication in peer-reviewed medical journals and presentation at relevant conferences.

Registration details: International standard randomised controlled trial number (ISRCTN) 10853487.

Strengths and limitations of this study:
•To our knowledge this is the first prospective randomised trial designed to assess the treatment of BPV following acute ischaemic stroke/TIA.
•The protocol incorporates multiple BP measurement methods.
•The chosen therapeutic interventions are in line with standard clinical practice for secondary stroke prevention.
•The trial is open-label which could bias the analysis of treatment effects on BPV and any impact on stroke outcomes, but these are secondary exploratory outcomes in this feasibility trial.

Details

Original languageEnglish
JournalBMJ Open
Early online date9 Feb 2019
DOIs
StateE-pub ahead of print - 9 Feb 2019
Peer-reviewedYes

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