Do two different types of blood pressure lowering therapy (Calcium Channel Blockers or Angiotensin Converting Enzyme Inhibitor/Angiotensin receptor blockers) have similar effects on reducing Blood pressure levels and variability following acute ischaemic Stroke or TIA (CAARBS): A Feasibility Trial

Phase 1

• Conditions: 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 disorders; MedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: PT Classification code 10044390 Term: Transient ischaemic attack System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0 Level: LLT Classification code 10020783 Term: Hypertension not adequately controlled System Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0 Level: LLT Classification code 10036695 Term: Primary hypertension System Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002560-41-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Study Completion: 2019-03-31
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

Patients aged over 18 with a first TIA or mild to moderate ischaemic stroke (NIHSS <10) and blood pressure >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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified