Deans' stroke musings: The second randomized controlled ENhanced Control of Hypertension ANd Thrombectomy strokE stuDy (ENCHANTED2): protocol and progress

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Wednesday, August 10, 2022

The second randomized controlled ENhanced Control of Hypertension ANd Thrombectomy strokE stuDy (ENCHANTED2): protocol and progress

You lazy blithering idiots. Your objective is to create a blood pressure management protocol post stroke, not this lazy crapola of effectiveness and safety.

The second randomized controlled ENhanced Control of Hypertension ANd Thrombectomy strokE stuDy (ENCHANTED2): protocol and progress

Show all authors

Lili Song *

, Pengfei Yang *, Yong-Wei Zhang *, ...

First Published August 4, 2022 Research Article

Abstract

Background:

Uncertainty exists over the optimal level of blood pressure (BP) after mechanical thrombectomy (MT) for acute ischemic stroke (AIS).

Objectives:

We aim to determine the effectiveness and safety of intensive BP-lowering following MT reperfusion of large-vessel occlusion (LVO) related AIS.

Design:

ENCHANTED2 is an investigator-initiated, multicenter, prospective, randomized, open, blinded-endpoint (PROBE) trial of intensive systolic BP (SBP) control in reperfused (extended thrombolysis in cerebral infarction [eTICI] classification 2b/2c/3) LVO-AIS patients with persistent hypertension (SBP ≥140mmHg) at 60+ sites in China, and Australia and the UK. Eligible patients are centrally randomly allocated to more-intensive (target SBP ≤120mmHg within 1 hour) or less-intensive (target SBP 140-180mmHg) BP management, to be maintained for 72 hours. Primary outcome is an ordinal shift analysis of scores on the modified Rankin scale (mRS) at 90 days. Sample size of 2257 patients provides 90% power to detect a 6.5% absolute reduction in poor outcome from more-intensive BP lowering using ordinal logistic regression.

Progress:

Recruitment started in China in July 2020. At a meeting of the independent Data and Safety Monitoring Board in March 2022 to review primary outcome data available for 347 patients, they recommended suspension of recruitment due to safety concerns in the more-intensive group; which was implemented by the Trial Steering Committee (TSC) with 817 randomized patients only in China. The TSC then stopped recruitment after the safety concerns persisted on further review of the data in June 2022. The TSC will make a decision on restarting the trial with modification of the protocol when the results are made public.

Discussion:

ENCHANTED2 will provide further randomized evidence on the role of intensive BP lowering after reperfusion in MT-treated AIS patients.

Trial registration: ClinicalTrials.gov NCT04140110; registered 25 October 2019.

Keywords

Acute stroke therapy, Blood pressure, Clinical trial, Hypertension, Ischaemic stroke, Protocols, Reperfusion