Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial
NCT ID: NCT06352619
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2024-10-11
2026-05-31
Brief Summary
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Detailed Description
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Background and Rationale - Different reperfusion status may have different BP patterns. A U-shaped correlation between post-EVT BP and outcomes may exist for patients who underwent recanalisation post-EVT. In addition, different BP lowering strategy may have different safety profiles and may potentially impact differently with regards to the risk of ICH for patients with reperfusion therapy.
The controversial overall clinical effect seen in clinical trials, including ENCHANTED2/MT, OPTIMAL BP, BP TARGET, BEST II and ENCHANTED, does not resolve the question over the optimal BP control strategy following EVT. The evidence is insufficient to make sensible recommendations over the optimal BP management in this important clinical group. Thus, the Blood Pressure Domain (ENCHANTED3/MT) aims to test different treatment approaches to the control of elevated SBP post-EVT in AIS patients to find the optimal BP management that leads to improved functional status with reduced ICH and no other harms.
ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to the following three BP lowering management strategies.
Primary outcome is modified Rankin scale (mRS) at 90 days analysed with utility-weighted mRS using a Bayesian hierarchical linear model. Adaptive analyses will be conducted 3-monthly with prespecified statistical triggers for superiority, inferiority and equivalence.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conservative SBP Control
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
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
Intensive SBP Control
SBP reduction by 30-50mmHg or a target of 140±5 mmHg, which is higher
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Changhai Hospital
OTHER
The George Institute
OTHER
Responsible Party
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Principal Investigators
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Craig Anderson, PhD
Role: PRINCIPAL_INVESTIGATOR
The George Institute
Locations
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The George Institute for Global Health
Sydney, New South Wales, Australia
University of Calgary
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Carol C Kenney, RN
Role: primary
Michael D Hill, MD
Role: backup
Related Links
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ACT-GLOBAL Master Protocol Registration
Other Identifiers
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ACT-GLOBAL_AIS_03
Identifier Type: -
Identifier Source: org_study_id
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