Recruiting

Hypertension & Thrombectomy

Sponsor:

The George Institute

Code:

NCT06352619

Conditions

Ischemic Stroke, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conservative SBP Control

Moderate SBP Control

Intensive SBP Control

Study Details

Brief summary:

Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP <130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[≥180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management.

Conditions

Ischemic Stroke, Acute

Study ID

NCT06352619

Start date

Oct 11, 2024

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years;
2. Use of endovascular therapy (EVT) within 24 hours of symptom onset or last known well according to local guidelines;
3. Sustained high systolic blood pressure ≥150 mmHg (2 readings <10 mins apart) within 3 hours after completion of EVT.

Exclusion Criteria:

1.Any definite contraindications to BP lowering treatment.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Conservative SBP Control

experimental: Moderate SBP Control

experimental: Intensive SBP Control

Interventions

Conservative SBP Control

No or minimal treatment; if there is a need to treat a patient with a very-high (>180 mmHg) baseline SBP, then the SBP reduction is 5-10mmHg or a target is 175-180 mmHg

Moderate SBP Control

If the patient has a very high (>180 mmHg) or moderate high (160-180 mmHg) baseline SBP, SBP reduction is 10-20mmHg or a target of160±5 mmHg, which is higher; patients with low-high (150-160 mmHg) baseline SBP will not be treated

Intensive SBP Control

SBP reduction by 30-50mmHg or a target of 140±5 mmHg, which is higher

Primary outcome measure

  • modified Rankin scale [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Xiaoying Chen, PhD

+61 2 8052 4549xchen@georgeinstitute.org.au

Craig Anderson, PhD

+61 2 8052 4521canderson@georgeinstitute.org.au

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

More Information

Sponsor

The George Institute

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Blood Pressure
  • Endovascular Therapy
  • Ischemic Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The George Institute on 2026-07-08.