Condition category
Circulatory System
Date applied
12/02/2009
Date assigned
18/02/2009
Last edited
07/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.bham.ac.uk/

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

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20696047
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26919870

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

07/07/2016: Publication reference added.