Contact information
Type
Scientific
Primary contact
Prof Jonathan Mant
ORCID ID
Contact details
Primary Care Clinical Sciences
School of Health and Population Studies
Primary Care Clinical Sciences Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 2657
jm677@medschl.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RG_08_076
Study information
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
Acronym
Past BP
Study hypothesis
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
Warwickshire Research Ethics Committee, 22/12/2008, ref: 08 H12111 21
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/07/2008
Overall trial end date
31/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants that are aged 18 years and over (either sex), on the practice TIA/stroke register with a validated diagnosis.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
610
Participant 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
Recruitment start date
01/07/2008
Recruitment end date
31/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
c/o Dr Brendan Laverty
Department of Research and Commercial Services
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
b.w.laverty@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: RP-PG-0606-1153)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20696047
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26919870
Publication citations
-
Protocol
Fletcher K, Mant J, McManus R, Campbell S, Betts J, Taylor C, Virdee S, Jowett S, Martin U, Greenfield S, Ford G, Freemantle N, Hobbs FD, 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., BMC Cardiovasc Disord, 2010, 10, 37, doi: 10.1186/1471-2261-10-37.
-
Results
Mant J, McManus RJ, Roalfe A, Fletcher K, Taylor CJ, Martin U, Virdee S, Greenfield S, Hobbs FD, Different systolic blood pressure targets for people with history of stroke or transient ischaemic attack: PAST-BP (Prevention After Stroke--Blood Pressure) randomised controlled trial, BMJ, 2016, 352, i708, doi: 10.1136/bmj.i708.