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| [ ...Back to search results ] | [ Print-friendly version ] |
| Different blood pressure targets for people with a history of stroke or transient ischaemic attack (TIA) in Primary Care Clinical Sciences care |
| ISRCTN | ISRCTN29062286 |
| ClinicalTrials.gov identifier | |
| Public title | Different blood pressure targets for people with a history of stroke or transient ischaemic attack (TIA) in Primary Care Clinical Sciences care |
| 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 |
| Serial number at source | RG_08_076 |
| 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? |
| Lay summary | |
| Ethics approval | Warwickshire Research Ethics Committee gave approval on the 22nd December 2008 (ref: 08 H12111 21) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke prevention |
| Participants - inclusion criteria | Participants that are aged 18 years and over (either sex), on the practice TIA/stroke register with a validated diagnosis. |
| Participants - 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 |
| Anticipated start date | 01/07/2008 |
| Anticipated end date | 31/07/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 610 |
| Interventions |
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. |
| Primary outcome measure(s) | Change in systolic blood pressure between baseline and twelve months. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: RP-PG-0606-1153) |
| Trial website | |
| Publications | 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20696047 |
| Contact name | Prof Jonathan Mant |
| Address |
Primary Care Clinical Sciences
School of Health and Population Studies Primary Care Clinical Sciences Building University of Birmingham Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 414 2657 |
| Fax | +44 (0)121 414 3759 |
| jm677@medschl.cam.ac.uk | |
| Sponsor | University of Birmingham (UK) |
| Address |
c/o Dr Brendan Laverty
Department of Research and Commercial Services Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 414 7618 |
| b.w.laverty@bham.ac.uk | |
| Sponsor website: | http://www.bham.ac.uk/ |
| Date applied | 12/02/2009 |
| Last edited | 16/08/2010 |
| Date ISRCTN assigned | 18/02/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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