Antihypertensives to reduce blood pressure variability after stroke

Phase 4

Completed

• Conditions: Specialty: Stroke, Primary sub-specialty: Prevention; UKCRC code/ Disease: Stroke/ Cerebrovascular diseases, Cardiovascular/ Other and unspecified disorders of the circulatory system; Circulatory System; Stroke, Hypertension

• Registration Number: ISRCTN10853487
• Lead Sponsor: niversity of Leicester

Brief Summary

2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30782930 (added 11/03/2020) 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32151851 (added 11/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-24
• Study Completion: 2019-07-31
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Participant inclusion criteria as of 24/09/2018:
1. Adult patients (male and female) aged over 18
2. First episode TIA or mild to moderate ischaemic stroke (NIHSS <10)
3. Blood pressure >130/80mmHg
4. Within 7 days of symptom onset
5. Willing to comply with randomly assigned blood pressure treatment and blood pressure measurements
6. Able to understand verbal and written English
7. Able to provide informed consent
8. Willing for their GP to be notified of their involvement in the study

Previous participant inclusion criteria:
1. Adult patients (male and female) aged over 18
2. First episode TIA or mild to moderate ischaemic stroke (NIHSS <10)
3. Blood pressure >130/80mmHg
4. Within 72 hours of symptom onset
5. Willing to comply with randomly assigned blood pressure treatment and blood pressure measurements
6. Able to understand verbal and written English
7. Able to provide informed consent
8. Willing for their GP to be notified of their involvement in the study

Exclusion Criteria

1. Known definite contra-indication to BP-lowering regime or therapeutic agents
2. Swallowing difficulties which would preclude the taking of oral medication
3. Definite indication for beta blocker, calcium channel blocker, angiotensin converting enzyme inhibitor, or angiotensin receptor blocker therapy
4. Significant pre-stroke dependency (modified Rankin Score >3)
5. Co-existing life-threatening condition with life expectancy <3 months
6. Previous participation in this trial or current participation in another investigational drug trial
7. Atrial fibrillation
8. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
9. Participants who intend to donate blood during the study
10. Unable to understand verbal and written English
11. Cannot give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Feasibility and acceptability of study is measured using recruitment rates and reasons for non-eligibility at the end of the study<br> 2. The proposed primary outcome for the future study is the stroke outcome as assessed using the modified Rankin Score at 90 days<br>