Acute Ischemic StrokeENCHANTED2NCT04140110

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

A study testing Intensive BP lowering in people with Acute Ischemic Stroke, run by The George Institute for Global Health, China at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Ischemic Stroke
What is being tested?: Intensive BP lowering
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 816 participants
Where: 1 siteChina
Study dates: 20 Jul 2020to 31 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Read the detailed description

Objectives: To determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to higher BP management target (140-180mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to large vessel occlusion (LVO).

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Outcome Measures Primary outcome: functional recovery, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days.

Secondary outcomes: any intracranial haemorrhage (ICH), symptomatic intracerebral haemorrhage (sICH), early neurological deterioration, imaging assessment (e.g. infarct size, edema volume), death, disability, HRQoL, duration of hospitalization, residence; and health service use for calculation of resources and costs.

Randomisation and intervention: Randomisation is via a central internet-based system, stratified by site, time from symptom onset to recanalization (<6, ≥6 hours), baseline neurological impairment on the National Institutes for Health Stroke Scale (NIHSS <17 vs ≥17), to ensure balance in key prognostic factors.

Intensive BP lowering group: to commence intravenous BP lowering therapy immediately after randomization, with systolic BP target (<120 mmHg) achieved within 1 hour, and maintained for at least 72 hours (or hospital discharge if earlier).

Control group: to receive guideline-recommended BP control strategy to maintain BP level 140-180 mmHg after MT procedure, but BP lowering treatment given only for BP ≥150 mmHg to achieve target ≥140 mmHg.

Substudies: Patients enrolled in main study can also be randomised into 2 substudies according to separate eligibility criteria. Both are pilot studies embedded in main trial to recruit as many patients to inform sample size estimates for a further main study.

Substudy #1: Timing of anticoagulation Objective: To determine the effectiveness of early initiation of anticoagulation (at Day 4±2 of stroke onset) compared with late initiation (at Day 12±2) on a composite outcome of recurrent AIS, sICH, systemic embolism and/or death within 90 days in patients with AF-related AIS due to LVO who receive MT. Randomisation (allocation 1:1 ratio) via same system as main study and stratified by site and randomisation of BP intervention. Randomised patients will be allocated to either early group of initiating OAC therapy at Day 4±2 day of stroke onset, or late group of initiating OAC therapy at Day 12±2 of stroke onset. Primary outcome: composite of recurrent AIS, sICH, systemic embolism and/or vascular death within 90 days after randomisation.

Substudy #2: Duration of dual antiplatelet therapy (DAPT):

Objective: To determine the effectiveness of short duration of DAPT (<6 weeks) compared with standard duration (3 months or more) on recurrence rate within 12 months in patients with AIS due to large artery atherosclerosis (LAA) who are eligible for DAPT post-MT. Randomisation (allocation 1:1 ratio) will be done via the same system as the main study and stratified by site and randomisation of BP intervention. Randomised patients will be allocated to either short duration group of receiving DAPT (aspirin 100 mg and clopidogrel 75 mg per day) for 6 weeks, or standard duration group receiving DAPT for 3 months. DAPT is started <48 hours post-randomization, and maintained changed to antiplatelet monotherapy (aspirin or clopidogrel) thereafter. Primary outcome is new stroke event (AIS or ICH) over 12 months.

Conditions: Acute Ischemic Stroke
Being tested: Intensive BP lowering
Keywords: Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Blood pressure management, Antiplatelet therapy, Anticoagulation therapy, Randomised clinical trial
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive BP loweringOther
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).

Study groups in NCT04140110
Study group	Role	What they receive
Intervention group	Experimental	Achieving SBP level of <120 mmHg within 1 hour after randomisation, and maintaining this level at least 72 hours. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Level of disability
a shift (improvement) in scores (0-6) on the modified Rankin scale
Measured: 90 days (3 months)

Secondary outcomes (5)

intracerebral hemorrhage (ICH)
any or symptomatic ICH (sICH) after MT
Measured: 90 days
Imaging endpoints
infarct size growth
Measured: 24-48 hours
Imaging endpoints
edema volume
Measured: Day 7
Death or neurological severity
Death or dependency measured by National Institutes of Health stroke scale (NIHSS)
Measured: 7 days
Others
Death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); health-related quality of life (HRQoL) using EQ-5D; duration of hospitalisation; residence and hospital service cost.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202031 Oct 2022

First posted25 Oct 2019
Study start20 Jul 2020
Primary completion15 Jul 2022
Study completion31 Oct 2022

Why it stopped: Data Safety Monitoring Board recommendation based on consistent safety concerns that recruitment be discontinued and the data analysed and reported. Protocol amendment planned.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Different intensities of blood pressure management using locally available intravenous antihypertensive agents
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 816 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04140110
Sponsor's protocol ID: ENCHANTED2
Acronym: ENCHANTED2
Status last verified: Sep 2023
First submitted: 22 Oct 2019
Last updated: 13 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data can be shared with bona fide researchers after after publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.

Publications

Gu R, Ge M, Wang Z, Huyan M, Wang L, Gao Y, Zhang X, Zhang Y, Zhang L, Li Z, Xing P, Hua W, Shen F, Liu J, Shen H, Yang P; ENCHANTED2/MT investigators. Association of intensive blood pressure lowering with health-related quality of life after endovascular thrombectomy: a post-hoc analysis of the ENCHANTED2/MT trial. Qual Life Res. 2026 Jun 6;35(7):180. doi: 10.1007/s11136-026-04274-0.
PubMed 42250116
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.
PubMed 40330548
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.
PubMed 36341753
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.
PubMed 35924814

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Second Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED2)
ClinicalTrials.gov ID: NCT04140110
Acronym / sponsor ID: ENCHANTED2 / ENCHANTED2
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Blood pressure management, Antiplatelet therapy, Anticoagulation therapy, Randomised clinical trial
Study type: Interventional
Recruitment status: TerminatedReason stopped: Data Safety Monitoring Board recommendation based on consistent safety concerns that recruitment be discontinued and the data analysed and reported. Protocol amendment planned.
Enrolment: 816 participants (actual)
Lead sponsor: The George Institute for Global Health, ChinaUniversity, hospital or other
Collaborators: Changhai Hospital
Study start: 20 Jul 2020 (actual)
Primary completion: 15 Jul 2022 (actual)
Study completion: 31 Oct 2022 (actual)
First posted: 25 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Outcome Measures Primary outcome: functional recovery, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days.

Substudy #2: Duration of dual antiplatelet therapy (DAPT):

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Different intensities of blood pressure management using locally available intravenous antihypertensive agents

Arm	Type	Receives
Intervention group	Experimental	Other: Intensive BP loweringAchieving SBP level of <120 mmHg within 1 hour after randomisation, and maintaining this level at least 72 hours.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intensive BP loweringThe 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).	Other	Intervention group

Primary outcome

Level of disability
Time frame: 90 days (3 months)
a shift (improvement) in scores (0-6) on the modified Rankin scale

5 secondary outcomes

intracerebral hemorrhage (ICH)
Time frame: 90 days
Imaging endpoints
Time frame: 24-48 hours
Imaging endpoints
Time frame: Day 7
Death or neurological severity
Time frame: 7 days
Others
Time frame: 90 days

Results and safety

The study was stopped early (reason given: Data Safety Monitoring Board recommendation based on consistent safety concerns that recruitment be discontinued and the data analysed and reported. Protocol amendment planned.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Derived from this study: PubMed 42250116Gu R, Ge M, Wang Z, Huyan M, Wang L, Gao Y, Zhang X, Zhang Y, Zhang L, Li Z, Xing P, Hua W, Shen F, Liu J, Shen H, Yang P; ENCHANTED2/MT investigators. Association of intensive blood pressure lowering with health-related quality of life after endovascular thrombectomy: a post-hoc analysis of the ENCHANTED2/MT trial. Qual Life Res. 2026 Jun 6;35(7):180. doi: 10.1007/s11136-026-04274-0.
Derived from this study: PubMed 40330548Zhang 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.
Derived from this study: PubMed 36341753Yang 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.
Derived from this study: PubMed 35924814Song 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.
Individual participant dataSharing planned: Yes. Data can be shared with bona fide researchers after after publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.

Related trials for Acute Ischemic Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig Anderson principal investigator

The George Institute for Global Health, China

Jianmin Liu principal investigator

Changhai Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intensive BP lowering in people with Acute Ischemic Stroke, run by The George Institute for Global Health, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of disability (time frame: 90 days (3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140110, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.