Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial
Recruiting · NCT06352619 · Interventional (participants receive a specific treatment) · Lead sponsor: The George Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Any definite contraindications to BP lowering treatment.
Where it is running
2 locations listed.
- University of Calgary - Calgary, Alberta, Canada
- The George Institute for Global Health - Sydney, New South Wales, Australia