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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06352619




Registration number
NCT06352619
Ethics application status
Date submitted
2/04/2024
Date registered
8/04/2024
Date last updated
21/11/2024

Titles & IDs
Public title
Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial
Scientific title
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)
Secondary ID [1] 0 0
ACT-GLOBAL_AIS_03
Universal Trial Number (UTN)
Trial acronym
ENCHANTED3/MT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke, Acute 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Conservative SBP Control
Other interventions - Moderate SBP Control
Other interventions - Intensive SBP Control

Experimental: Conservative SBP Control -

Experimental: Moderate SBP Control -

Experimental: Intensive SBP Control -


Other 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

Other interventions: 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

Other interventions: Intensive SBP Control
SBP reduction by 30-50mmHg or a target of 140±5 mmHg, which is higher
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
modified Rankin scale
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Excellent functional neurological outcome
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
Independent functional neurological outcome
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
Health Related Quality of Life
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Mortality
Timepoint [4] 0 0
90 days
Secondary outcome [5] 0 0
Ordinal shift of 7 levels of modified Rankin scale
Timepoint [5] 0 0
90 days
Secondary outcome [6] 0 0
National Institute of Health Stroke Scale (NIHSS) score
Timepoint [6] 0 0
24-48 hours
Secondary outcome [7] 0 0
Any intracranial haemorrhage (ICH)
Timepoint [7] 0 0
2 days
Secondary outcome [8] 0 0
Symptomatic intracerebral haemorrhage (sICH)
Timepoint [8] 0 0
2 days
Secondary outcome [9] 0 0
Serious Adverse Event (SAE)
Timepoint [9] 0 0
4 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Any definite contraindications to BP lowering treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Calgary
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Changhai Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06352619
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Anderson, PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaoying Chen, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4549
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06352619