Second Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED2)

NCT04140110 | Terminated DMC

• 1 other identifier: ENCHANTED2
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 1

Brief Summary

ENCHANTED2 is an international, multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to assess different approaches to manage blood pressure (BP) in acute ischemic stroke (AIS) patients who have undergone mechanical thrombectomy (MT). There are two nested substudies evaluating different approaches to secondary prevention in this high-risk stroke population.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Large vessel occlusion; Mechanical thrombectomy; Blood pressure management; Antiplatelet therapy; Anticoagulation therapy; Randomised clinical trial

Outcome Measures

Primary Outcomes (1)

• Level of disability

  a shift (improvement) in scores (0-6) on the modified Rankin scale

  90 days (3 months)

Secondary Outcomes (5)

• intracerebral hemorrhage (ICH)

  90 days

• Imaging endpoints

  24-48 hours

• Imaging endpoints

  Day 7

• Death or neurological severity

  7 days

• Others

  90 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Achieving SBP level of \<120 mmHg within 1 hour after randomisation, and maintaining this level at least 72 hours.

Other: Intensive BP lowering

Control group

NO INTERVENTION

Maintaining SBP 140-180mmHg, and BP lowering treatment can be given only when BP level ≥150 mmHg in order to achieve the target of ≥140 mmHg, and maintaining this level at least 72 hours.

Interventions

Intensive BP lowering OTHER

The aim is to achieve a systolic BP level of \<120mmHg within 1 hour after randomisation and to maintain this BP level for the next 72 hours (or until hospital discharge or death if this should occur earlier).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years; Diagnosis of AIS with LVO confirmed by brain imaging; To receive MT \<24 hours after AIS onset according to local guidelines; Successful recanalization (TICI score ≥2b) after MT; Sustained systolic BP ≥140 mmHg (defined as 2 successive readings \<10 mins) within 3 hours after recanalization; Provide written informed consent (or approved surrogate).

You may not qualify if:

• Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician; Other medical illness that interferes with outcome assessments and follow-up (e.g. known significant pre-stroke disability (mRS scores 3-5), advance cancer and renal failure); Definite indication/contraindication to different intensities of BP lowering treatment; Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients); Patients with aortic isthmus stenosis and arteriovenous shunt (exception: patients with haemodynamically inactive dialysis shunt); Women who are lactating; Currently participating in another trial which would interfere with outcome assessments.

Sponsors & Collaborators

• The George Institute for Global Health, China: lead
• Changhai Hospital: collaborator

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (3)

• Zhang X, Ren X, Zhang Y, Zhang Y, Zhang L, Shen H, Li Z, Xing P, Zhang P, Hua W, Shen F, Tian B, Chen W, Han H, Zhang L, Xu C, Li T, Gao Y, Zhou Y, Zuo Q, Dai D, Zhao R, Li Q, Huang Q, Xu Y, Chen X, Li Q, Song L, Anderson CS, Yang P, Liu J; ENCHANTED2/MT Collaboration. Interaction of brain imaging features and effects of intensive blood pressure lowering after endovascular treatment for acute ischaemic stroke: the pre-specified secondary analyses of ENCHANTED2/MT trial. EClinicalMedicine. 2025 Apr 21;83:103197. doi: 10.1016/j.eclinm.2025.103197. eCollection 2025 May.

  PMID: 40330548 DERIVED

• Yang P, Song L, Zhang Y, Zhang X, Chen X, Li Y, Sun L, Wan Y, Billot L, Li Q, Ren X, Shen H, Zhang L, Li Z, Xing P, Zhang Y, Zhang P, Hua W, Shen F, Zhou Y, Tian B, Chen W, Han H, Zhang L, Xu C, Li T, Peng Y, Yue X, Chen S, Wen C, Wan S, Yin C, Wei M, Shu H, Nan G, Liu S, Liu W, Cai Y, Sui Y, Chen M, Zhou Y, Zuo Q, Dai D, Zhao R, Li Q, Huang Q, Xu Y, Deng B, Wu T, Lu J, Wang X, Parsons MW, Butcher K, Campbell B, Robinson TG, Goyal M, Dippel D, Roos Y, Majoie C, Wang L, Wang Y, Liu J, Anderson CS; ENCHANTED2/MT Investigators. Intensive blood pressure control after endovascular thrombectomy for acute ischaemic stroke (ENCHANTED2/MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet. 2022 Nov 5;400(10363):1585-1596. doi: 10.1016/S0140-6736(22)01882-7. Epub 2022 Oct 28.

  PMID: 36341753 DERIVED

• Song L, Yang P, Zhang Y, Zhang X, Chen X, Li Y, Shen H, Zhang L, Li Z, Zhang Y, Xing P, Zhang P, Zhou Y, Ren X, Billot L, Wang X, Parsons MW, Butcher K, Campbell B, Robinson T, Goyal M, Dippel D, Roos Y, Majoie C, Liu J, Anderson CS; for ENCHANTED-MT Investigators. The second randomized controlled ENhanced Control of Hypertension ANd Thrombectomy strokE stuDy (ENCHANTED2): Protocol and progress. Int J Stroke. 2023 Mar;18(3):364-369. doi: 10.1177/17474930221120345. Epub 2022 Aug 24.

  PMID: 35924814 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Craig Anderson

  The George Institute for Global Health, China

  PRINCIPAL INVESTIGATOR

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open intervention; outcome assessments undertaken by trained research staff who are kept blind to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: Different intensities of blood pressure management using locally available intravenous antihypertensive agents

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: July 20, 2020
• Primary Completion: July 15, 2022
• Study Completion: October 31, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data sharing will be available from 12 months after publication of the main results.
• Access Criteria: 1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

Locations

CN (1)