Different blood pressure targets for people with a history of stroke or transient ischaemic attack (TIA) in Primary Care Clinical Sciences care

ISRCTN	ISRCTN29062286
DOI	https://doi.org/10.1186/ISRCTN29062286
Secondary identifying numbers	RG_08_076

Submission date: 12/02/2009
Registration date: 18/02/2009
Last edited: 07/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonathan Mant
Scientific

Primary Care Clinical Sciences
School of Health and Population Studies
Primary Care Clinical Sciences Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 2657
Email	jm677@medschl.cam.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of different blood pressure targets for people with a history of stroke or transient ischaemic attack (TIA) in primary care
Study acronym	Past BP
Study objectives	The principal question addressed by the study is whether having a more intensive blood pressure (BP) target in patients who have had a stroke or transient ischaemic attack (TIA) in primary care will lead to a lower BP and what will be the impact on patient quality of life?
Ethics approval(s)	Warwickshire Research Ethics Committee, 22/12/2008, ref: 08 H12111 21
Health condition(s) or problem(s) studied	Stroke prevention
Intervention	Patients will be recruited from approximately 50 practices. Participants will be randomised to one of two treatment arms: 1. The intensive treatment arm will have a target systolic BP of 130 mmHg, or 10 mmHg reduction in systolic BP if baseline systolic BP is less than 140 mmHg 2. The standard treatment arm will have a target systolic BP of 140 mmHg as per current national guidelines Each patient will remain in the study for one year. Patients will be reviewed at 1 - 3 month intervals by their surgery practice nurse dependent on their level of blood pressure and referred to their GP if their blood pressure is raised. Both nurses and GPs will follow algorithms based on the National Clinical Guidelines for Hypertension with regard to sequencing of agents and dose. Patients will be followed up at 6 and 12 months after their initial appointment by the research team.
Intervention type	Other
Primary outcome measure	Change in systolic blood pressure between baseline and twelve months.
Secondary outcome measures	1. Additional measures of blood pressure: 1.1. Diastolic blood pressure: change between baseline and six months 1.2. Change in systolic and diastolic blood pressure between baseline and 12 months 1.3. Change in mean daytime ambulatory systolic BP between baseline and twelve months 2. Measures of adherence: 2.1. GP adherence to protocol will be monitored by analysis of treatment decisions made at each GP follow up in the first twelve months 2.2. Patient adherence with prescribed medication will be assessed using: 2.2.1. Morisky's four item self report scale (questionnaire) 2.2.2. Patient attendance at planned reviews by practice nurse/GP 2.2.3. Electronic prescription data. This will be extracted from the practice computer systems, and will provide information regarding maximum compliance in terms of number of prescriptions requested (number of days for which medication has been prescribed divided by total number of days in each follow up period). 3. Side effects and tolerability: 3.1. Symptom questionnaire 3.2. Quality of life: 36-item short form health survey (SF-36) and EQ-5D questionnaires 4. Clinical end-points: major cardiovascular events (composite of fatal and non-fatal stroke, myocardial infarction or fatal coronary heart disease and other cardiovascular death) obtained through practice data 5. Other clinical outcome measures: 5.1. All cause mortality 5.2. Cognitive function (Mini Mental State Examination [MMSE] questionnaire) 5.3. Hospital admissions classified by discharge diagnosis 5.4. The individual components of the Primary Care Clinical Sciences care clinical outcome measure 6. Adverse events: additional adverse events (other than those covered by the outcome measures described above) will be recorded at six and twelve months 7. Resource use and costs: health sector and private sector use and costs will be recorded at six and twelve months on the case report form
Overall study start date	01/07/2008
Completion date	31/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	610
Key inclusion criteria	Participants that are aged 18 years and over (either sex), on the practice TIA/stroke register with a validated diagnosis.
Key exclusion criteria	Participants that: 1. Have systolic BP less than 125 mmHg at baseline 2. Are already taking three or more anti-hypertensive agents; orthostatic hypotension (greater than 20 mmHg postural change in systolic BP) 3. Have diabetes mellitus with microalbuminuria or other condition for which a patient has a lower treatment target specified
Date of first enrolment	01/07/2008
Date of final enrolment	31/07/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

c/o Dr Brendan Laverty
Department of Research and Commercial Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Phone	+44 (0)121 414 7618
Email	b.w.laverty@bham.ac.uk
Website	http://www.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: RP-PG-0606-1153)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	09/08/2010		Yes	No
Results article	results	24/02/2016		Yes	No

Editorial Notes

07/07/2016: Publication reference added.