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

Humans Stroke / therapy Prospective Studies Ischemic Stroke Treatment Outcome Hypertension / drug therapy Thrombectomy Brain Ischemia / drug therapy Randomized Controlled Trials as Topic Multicenter Studies as Topic
Acute ischemic stroke blood pressure lowering clinical trial hypertension mechanical thrombectomy outcomes thrombolysis

Journal

International journal of stroke : official journal of the International Stroke Society
ISSN: 1747-4949
Titre abrégé: Int J Stroke
Pays: United States
ID NLM: 101274068

Informations de publication

Date de publication:
03 2023
Historique:
pubmed: 5 8 2022
medline: 25 2 2023
entrez: 4 8 2022
Statut: ppublish

Résumé

Uncertainty exists over the optimal level of blood pressure (BP) after mechanical thrombectomy (MT) for acute ischemic stroke (AIS). We aim to determine the effectiveness and safety of intensive BP-lowering following MT reperfusion of large-vessel occlusion (LVO)-related AIS. The second ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED2) is an investigator-initiated, multicenter, prospective, randomized, open, blinded-endpoint (PROBE) trial of intensive systolic BP (SBP) control in reperfused (extended treatment in cerebral infarction (eTICI) classification 2b/2c/3) LVO-AIS patients with persistent hypertension (SBP ⩾ 140 mmHg) at 60+ sites in China, and Australia and the United Kingdom. Eligible patients are centrally randomly allocated to more- (target SBP ⩽ 120 mmHg within 1 h) or less-intensive (target SBP 140-180 mmHg) BP management, to be maintained for 72 h. 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. 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. ENCHANTED2 will provide further randomized evidence on the role of intensive BP-lowering after reperfusion in MT-treated AIS patients. ClinicalTrials.gov NCT04140110; registered 25 October 2019.

Sections du résumé

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
The second ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED2) is an investigator-initiated, multicenter, prospective, randomized, open, blinded-endpoint (PROBE) trial of intensive systolic BP (SBP) control in reperfused (extended treatment in cerebral infarction (eTICI) classification 2b/2c/3) LVO-AIS patients with persistent hypertension (SBP ⩾ 140 mmHg) at 60+ sites in China, and Australia and the United Kingdom. Eligible patients are centrally randomly allocated to more- (target SBP ⩽ 120 mmHg within 1 h) or less-intensive (target SBP 140-180 mmHg) BP management, to be maintained for 72 h. 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.

Identifiants

DOI: 10.1177/17474930221120345 PMID: 35924814
pubmed: 35924814
doi: 10.1177/17474930221120345
doi:

Banques de données

ClinicalTrials.gov
['NCT04140110']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

364-369

Auteurs

Lili Song (L)

The George Institute for Global Health China, Beijing, China.
The George Institute for Global Health, Faculty of Medicine, The University of New South Wales (UNSW), Sydney, NSW, Australia.
ORCID: 0000-0002-6105-1720

Pengfei Yang (P)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Yongwei Zhang (Y)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Xiaoxi Zhang (X)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Xiaoying Chen (X)

The George Institute for Global Health China, Beijing, China.
The George Institute for Global Health, Faculty of Medicine, The University of New South Wales (UNSW), Sydney, NSW, Australia.
ORCID: 0000-0002-8367-542X

Yunke Li (Y)

The George Institute for Global Health China, Beijing, China.

Hongjian Shen (H)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Lei Zhang (L)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Zifu Li (Z)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Yongxin Zhang (Y)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Pengfei Xing (P)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
ORCID: 0000-0002-2663-1092

Ping Zhang (P)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Yihan Zhou (Y)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Xinwen Ren (X)

The George Institute for Global Health China, Beijing, China.

Laurent Billot (L)

The George Institute for Global Health, Faculty of Medicine, The University of New South Wales (UNSW), Sydney, NSW, Australia.
ORCID: 0000-0002-4975-9793

Xia Wang (X)

The George Institute for Global Health, Faculty of Medicine, The University of New South Wales (UNSW), Sydney, NSW, Australia.
ORCID: 0000-0002-1684-7076

Mark W Parsons (MW)

Ingham Institute for Applied Medical Research, Liverpool Hospital, The University of New South Wales (UNSW), Sydney, NSW, Australia.

Ken Butcher (K)

Prince of Wales Clinical School, The University of New South Wales (UNSW), Sydney, NSW, Australia.

Bruce Campbell (B)

Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.
ORCID: 0000-0003-3632-9433

Thompson Robinson (T)

Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.

Mayank Goyal (M)

Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada.
ORCID: 0000-0001-9060-2109

Diederik Dippel (D)

Department of Neurology, Erasmus MC, Rotterdam, The Netherlands.
ORCID: 0000-0002-9234-3515

Yvo Roos (Y)

Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.

Charles Majoie (C)

Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.

Jianmin Liu (J)

Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Craig S Anderson (CS)

The George Institute for Global Health China, Beijing, China.
The George Institute for Global Health, Faculty of Medicine, The University of New South Wales (UNSW), Sydney, NSW, Australia.
Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.
ORCID: 0000-0002-7248-4863

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