Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL_ENCHANTED3/MT)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
The George Institute for Global Health
RECRUITING
Sydney
Canada
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Xiaoying Chen, PhD
xchen@georgeinstitute.org.au
+61 2 8052 4549
Backup
Craig Anderson, PhD
canderson@georgeinstitute.org.au
+61 2 8052 4521
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2026-05
Participants
Target number of participants: 2000
Treatments
Experimental: Conservative SBP Control
Experimental: Moderate SBP Control
Experimental: Intensive SBP Control
Related Therapeutic Areas
Sponsors
Leads: The George Institute
Collaborators: University of Calgary, Changhai Hospital

This content was sourced from clinicaltrials.gov