Status:
COMPLETED
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
The Stroke Association, United Kingdom
Conditions:
Ischemic Stroke
High Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, whi...
Detailed Description
This study is an international, multicentre, prospective, fixed-time point (optional) randomisation for two arms (\[A\] 'dose of rtPA' and \[B\] 'level of BP control'), open-label, blinded endpoint (P...
Eligibility Criteria
Inclusion
- Adult (age ≥18 years)
- A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging
- Able to receive treatment within 4.5 hours after the definite time of onset of symptoms
- Have a systolic BP ≤185 mmHg
- Provide informed consent (or via an appropriate proxy, according to local requirements)
- Specific criteria for arm \[A\] of low-dose vs standard-dose rtPA (Recruitment completed in August 2015.):
- Able to receive either low-dose or standard-dose rtPA
- Specific criteria for arm \[B\] of intensive BP lowering vs guideline recommended BP control
- Patient will or has received thrombolysis treatment with rtPA, either randomised dose within the trial or physician decided dose rtPA outside of the trial
- Sustained elevated systolic BP level, defined as 2 readings ≥ 150 mmHg
- Able to commence intensive BP lowering treatment within 6 hours of stroke onset
- Able to receive either immediate intensive BP lowering or conservative BP management
Exclusion
- Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset.
- Other medical illness that interferes with outcome assessments and follow-up \[known significant pre-stroke disability (mRS scores 2-5)\].
- Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used.
- Participation in another clinical trial involving evaluation of pharmacological agents.
- Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
4587 Patients enrolled
Trial Details
Trial ID
NCT01422616
Start Date
March 1 2012
End Date
August 1 2018
Last Update
October 13 2021
Active Locations (1)
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1
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050