Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT01422616
• Date of registration: 23/08/2011
• Prospective Registration: Yes
• Primary sponsor: The George Institute
• Public title: Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) ENCHANTED
• Scientific title: An International Randomised Controlled Trial to Establish the Effects of Low-dose rtPA and the Effects of Early Intensive Blood Pressure Lowering in Patients With Acute Ischaemic Stroke
• Date of first enrolment: March 2012
• Target sample size: 4587
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01422616
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Craig S Anderson, MD
• Affiliation: The George Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ischemic Stroke

High Blood Pressure

Intervention(s)

Drug: Low-dose rtPA

Other: Intensive blood pressure (BP) lowering

Drug: Standard-dose rtPA

Other: BP management policies

Primary Outcome(s)

Combined death and disability [Time Frame: 90 days]

Secondary Outcome(s)

Death [Time Frame: at 7 and 90 days]

Length of initial acute hospital stay [Time Frame: within 90 days]

Admission to residential care [Time Frame: 90 days]

Disability [Time Frame: 90 days]

Any intracerebral hemorrhage (ICH) [Time Frame: any time during 90 days]

Death or disability by the alternative, ordinal shift analysis [Time Frame: 90 days]

Symptomatic intracerebral hemorrhage (ICH) [Time Frame: within 7 days]

Health service use [Time Frame: 90 days]

Recurrent acute myocardial infarction and ischemic stroke [Time Frame: within 90 days]

Death or disability in as treated per-protocol population [Time Frame: 90 days]

Death or neurological deterioration [Time Frame: 72 hours]

Health-related quality of life [Time Frame: 90 days]

Symptomatic intracerebral hemorrhage [Time Frame: 36 hours]

Neurological deterioration [Time Frame: 72 hours]

Secondary ID(s)

X11-0123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Health and Medical Research Council, Australia

Conselho Nacional de Desenvolvimento Científico e Tecnológico

The Stroke Association, United Kingdom

Takeda