Protocol for Past BP: a randomised controlled trial of different blood pressure targets for people with a history of stroke of transient ischaemic attack (TIA) in primary care

Provided by University of Birmingham Research Archive, E-prints Repository

Fletcher et al. BMC Cardiovascular Disorders 2010, 10:37
http://www.biomedcentral.com/1471-2261/10/37

STUDY PROTOCOL

Protocol for Past BP: a randomised controlled trial
of different blood pressure targets for people
with a history of stroke of transient ischaemic
attack (TIA) in primary care

Kate Fletcher^1*, Jonathan Mant², Richard McManus¹, Sarah Campbell¹, Jonathan Betts¹, Clare Taylor¹,
Satnam Virdee¹, Sue Jowett¹, Una Martin¹, Sheila Greenfield¹, Gary Ford³, Nick Freemantle¹, FD Richard Hobbs¹

Abstract

Background: Blood pressure (BP) lowering in people who have had a stroke or transient ischaemic attack (TIA)
leads to reduced risk of further stroke. However, it is not clear what the target BP should be, since intensification of
therapy may lead to additional adverse effects. PAST BP will determine whether more intensive BP targets can be
achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on
quality of life.

Methods/Design: This is a randomised controlled trial (RCT) in patients with a past history of stroke or TIA.
Patients will be randomised to two groups and will either have their blood pressure (BP) lowered intensively to a
target of 130 mmHg systolic, (or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg)
compared to a standard group where the BP will be reduced to a target of 140 mmHg systolic. Patients will be
managed by their practice at 1-3 month intervals depending on level of BP and followed-up by the research team
at six monthly intervals for 12 months.

610 patients will be recruited from approximately 50 general practices. The following exclusion criteria will be
applied: systolic BP <125 mmHg at baseline, 3 or more anti-hypertensive agents, orthostatic hypotension, diabetes
mellitus with microalbuminuria or other condition requiring a lower treatment target or terminal illness.

The primary outcome will be change in systolic BP over twelve months. Secondary outcomes include quality of
life, adverse events and cardiovascular events.

In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and
healthcare professionals understanding and views of BP management.

Discussion: The results of this trial will inform whether intensive blood pressure targets can be achieved in people
who have had a stroke or TIA in primary care, and help determine whether or not further research is required
before recommending such targets for this population.

Trial Registration: ISRCTN29062286

* Correspondence: [email protected]

¹Primary Care Clinical Sciences, Clinical Sciences Building University of

Birmingham, Edgbaston Birmingham UK, B15 2TT

Full list of author information is available at the end of the article

© 2010 Fletcher et al; licensee BioMed Central Ltd.This is an Open Access article distributed underthe terms of the Creative Commons

BioIVIecI Central Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.

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