E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
|
E.1.1.1 | Medical condition in easily understood language |
A TIA/ischaemic stroke is due to a blood clot disrupting the blood supply to part of the brain. Hypertension is high blood pressure. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060840 |
E.1.2 | Term | Ischaemic cerebral infarction |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10044390 |
E.1.2 | Term | Transient ischaemic attack |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015488 |
E.1.2 | Term | Essential hypertension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020783 |
E.1.2 | Term | Hypertension not adequately controlled |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036695 |
E.1.2 | Term | Primary hypertension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066860 |
E.1.2 | Term | Uncontrolled hypertension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 months after recruitment to the trial. |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 weeks and 3 months after recruitment to the trial. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 30 |