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

A randomised controlled trial of different blood pressure targets for people with a history of stroke or transient ischaemic attack (TIA) in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29062286

Enrollment

610

Registered

2009-02-18

Start date

2008-07-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke prevention Circulatory System Stroke, not specified as haemorrhage or infarction

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants that are aged 18 years and over (either sex), on the practice TIA/stroke register with a validated diagnosis.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in systolic blood pressure between baseline and twelve months.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026