ENCHANTED: A Trial to assess the effects of low- vs standard-dose clot-busting and intensive vs standard blood pressure-lowering treatments on outcome after acute ischaemic stroke

Phase 1

• Conditions: Acute Ischaemic Stroke; MedDRA version: 18.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005545-12-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5000

Inclusion Criteria

The overall inclusion criteria for thrombolysis are: aged >18 years, clinical AIS diagnosis confirmed by brain imaging, able to receive treatment within 3 hours after definite onset time (though this time window may change with the forthcoming NICE Single Technology Appraisal review and further trial publications), SBP <185mmHg (patients with higher SBP levels can be treated provided the SBP level is reduced prior to commencement of treatment), and informed patient consent (or relative assent). In addition, specific criteria for the two arms include: [A] no definite indication or contraindication for either low- or standard-dose rtPA; and [B] sustained elevated SBP level (defined as 2 readings >150 and <185mmHg), and no definite indication or contraindication to either immediate ‘intensive’- or guideline-based BP control.
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients will be excluded if they are unlikely to benefit from therapy (e.g. advanced dementia, known severe pre-stroke disability (Modified Rankin score, mRS >3), or high likelihood of death within 24 hours), or other medical co-morbidities that interfere with outcome assessments or follow-up.

Study & Design

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