Clinical trial to establish the effects of low dose rtPA and the effects of early intensive blood pressure lowering in patients with acute ischaemic stroke

Phase 1

Conditions: Acute ischaemic stroke
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-002823-86-ES

Lead Sponsor: The George Institute for Global Health Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4800

Inclusion Criteria

- General criteria for use of thrombolytic treatment with rtPA.
(a)Adult (age >18 years)
(b)A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging
(c)Able to receive treatment within 4.5 hours after the definite time of onset of symptoms
(d)Have a systolic BP ?185 mmHg (i.e. the guideline recommended level of eligibility for rtPA; patients with higher BP levels at presentation can still be included provided the BP is reduced to the entry level prior to commencement of the randomised treatment)
(e)Provide informed consent (or via an appropriate proxy, according to local requirements)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

(a)Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset.
(b)Other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mRS scores 2-5)].
(c)Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used.
(d)Participation in another clinical trial involving evaluation of pharmacological agents
(e)Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.