Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial

NCT06352619 | Recruiting DMC

• 1 other identifier: ACT-GLOBAL_AIS_03
• Study Type: interventional
• Target: 2,000
• Locations: 2 countries
• Sites: 2

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

Keywords

Blood Pressure; Endovascular Therapy; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• modified Rankin scale

  The mRS is a 7-outcome ordered categorical scale that assesses functional neurological status after stroke. It is not intended for use as a measure of historical functional status. It is well accepted as a standard outcome around the world in the stroke community, by patients and by regulatory authorities. The seven values and the clinical summary of the individual scores are summarized in the following: 0 = No symptoms 1. = No significant disability; able to carry out all usual activities 2. = Slight disability; can look after own affairs, but unable to carry out all previous activities 3. = Moderate disability; require some help 4. = Moderately severe disability; unable to attend to own bodily needs without assistance 5. = Severe disability; bedridden and requiring constant nursing care and attention 6. = Dead

  90 days

Secondary Outcomes (9)

• Excellent functional neurological outcome

  90 days

• Independent functional neurological outcome

  90 days

• Health Related Quality of Life

  90 days

• Mortality

  90 days

• Ordinal shift of 7 levels of modified Rankin scale

  90 days

Study Arms (3)

Conservative SBP Control

EXPERIMENTAL

Other: Conservative SBP Control

Moderate SBP Control

EXPERIMENTAL

Other: Moderate SBP Control

Intensive SBP Control

EXPERIMENTAL

Other: Intensive SBP Control

Interventions

Conservative SBP Control OTHER

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

Conservative SBP Control

Moderate SBP Control OTHER

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

Moderate SBP Control

Intensive SBP Control OTHER

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

Intensive SBP Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Any definite contraindications to BP lowering treatment.

Sponsors & Collaborators

• The George Institute: lead
• University of Calgary: collaborator
• Changhai Hospital: collaborator

Study Sites (2)

The George Institute for Global Health

Sydney, New South Wales, 2000, Australia

RECRUITING

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Related Links

• ACT-GLOBAL Master Protocol Registration

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, PhD

  The George Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoying Chen, PhD

CONTACT

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

Craig Anderson, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: October 11, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared after publication of the main results.
• Access Criteria: Data can be shared after publication of the main results, based on approval of a submitted protocol to the Publication Committee. Data can be shared to bona fide researchers with experience in medical research, and with no conflict of interest that may potentially influence their interpretation of any analyses, and employed by a recognised academic institute, health service organisation, commercial research organisation of from the pharmaceutical industry. The data sharing will be only for analyses within the constraints of the consent under which the data were originally gathered consent. Data sharing with industry will be according to relevant contracts with appropriate approvals from all stake holders.

Locations

AU (1); CA (1)