Participants in the trial will have had a transient ischaemic attack (TIA) or an acute ischaemic stroke and will also have hypertension. The trial will investigate the possible treatment of blood pressure variability post-TIA/stroke using antihypertensive medications. MedDRA version: 20.1 Level: PT Classification code 10060840 Term: Ischaemic cerebral infarction System Organ Class: 10029205 - Nervous system disorde
Conditions
Interventions
Trade Name: Amlodipine
Product Name: C08CA
Pharmaceutical Form: Tablet
Product Name: C09AA
Pharmaceutical Form: Tablet
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged over 18 with a first TIA or mild to moderate ischaemic stroke (NIHSS 130/80mmHg, will be recruited within 72 hours of symptom onset. Patients must be willing to comply with the randomly assigned BP-lowering regime and BP measurements, be able to understand written and verbal English and provide informed patient consent, and be willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: Patients may not enter the trial if any of the following apply: Known definite contra-indication to BP-lowering regime or therapeutic agents; Swallowing difficulties which would preclude the taking of oral medication; Definite indication for beta-blocker, calcium channel blocker, angiotensin converting enzyme inhibitor, or angiotensin receptor blocker therapy; Significant pre-stroke dependency (modified Rankin Score >3); Co-existing life-threatening condition with life expectancy <3 months; Previous participation in this trial or current participation in another investigational drug trial; Atrial fibrillation; Female participants who are pregnant, lactating or planning pregnancy during the course of the study; Participants who intend to donate blood during the study; Unable to understand written and verbal English Cannot give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this feasibility study, patient recruitment and reasons for non-eligibility will be recorded. Accordingly, a screening log of all patients referred to the stroke services will be collected, and the reasons for non-inclusion in the study recorded.;Timepoint(s) of evaluation of this end point: 3 months after recruitment to the trial.; Secondary Objective: In this feasibility study, the following secondary feasibility and safety objectives will be recorded: 1. Feasibility a) Blood pressure variability: Changes in blood pressure variability from baseline to 21 (+/- 7) days and 90 (+/- 14) days by treatment arm. b) Compliance: Treatment compliance rates for each randomisation arm will be reported. Completion of and failure rates for BPV measurements at days 21 (+/- 7) and 90 (+/- 14) will be reported. 2. Safety Serious adverse events, including recurrent TIA/ stroke, MI, other systemic embolic events, death and hospital re-admission will be recorded up to 3 months. 3. Treatment discontinuation rates and reasons recorded. ; Primary end point(s): In this feasibility study, the primary objective is to establish patient recruitment and reasons for non-eligibility to inform a future definitive study. Accordingly, a screening log of all patients referred to the stroke services will be collected, and the reasons for non-inclusion in the study recorded. The proposed primary endpoint for the future definitive study is 90-day modified Rankin score and this will also be tested in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In this feasibility study, the following secondary feasibility objectives will be recorded: Blood pressure variability: Changes in blood pressure variability from baseline to 21 (+/- 7) days and 90 (+/- 14) days by treatment arm. Compliance: Treatment compliance rates for each randomisation arm will be reported. Completion of and failure rates for BPV measurements at days 21 (+/- 7) and 90 (+/- 14) will be reported. The following secondary safety objectives will be recorded: Serious adverse events, including recurrent TIA/ stroke, MI, other systemic embolic events, death and hospital re-admission will be recorded up to 3 months. Treatment discontinuation rates and reasons recorded. The proposed secondary endpoints for the future definitive study that will be tested are: Early (21 (+/- 7) days) Modified Rankin score National Institutes of Health Stroke Scale score Mean blood pressure Blood pressure variability Late (90 (+/- 14) days) Montreal cognitive assessment score Mean blood pressure Blood pressure variability ;Timepoint(s) of evaluation of this end point: 3 weeks and 3 months after recruitment to the trial. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Thompson Robinson
University of Leicester
Outcome results
None listed