Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) "ENCHANTED"

Recruiting

Phase 3 Results N/A

Eligibility 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:
- 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.