Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT00120003
Eligibility Criteria:
Inclusion Criteria:
* Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour)
* Systolic blood pressure ≥ 140 mm Hg
* Trial treatment possible within 30 hrs of symptom onset. If time of onset is not known, use the time when the patient was last known to be well.
* Consent (subsidiary, assent from legal acceptable representative, or waiver of consent)
* Age \>18 years
Exclusion Criteria:
* Markedly reduced consciousness (i.e. Scandinavian Stroke Scale consciousness score ≤ 2)
* Patient already receiving AT1 receptor blocker
* Contraindication to treatment with AT1 receptor blocker, e.g.:
* known renal failure (women: creatinine ≥ 150 µmol/L; men: ≥ 180 µmol/L)
* previously diagnosed bilateral renal artery stenosis
* previously diagnosed high-grade aortic stenosis
* previously diagnosed seriously impaired liver function and/or cholestasis
* known intolerance to candesartan or other tablet ingredients
* Clear indication, in the clinician's view, for start of treatment with AT1 receptor blocker during the treatment period (e.g. chronic heart failure grade III-IV, in the presence of intolerance to ACE inhibitors)
* Clear indication, in the clinician's view, for antihypertensive therapy during the acute phase of stroke (i.e. concurrent hypertensive encephalopathy or aortic dissection, or other situations)
* Other serious or life-threatening disease before the stroke:
* Patient severely mentally or physically disabled (e.g. Mini Mental Status score \< 20, or modified Rankin Scale score ≥ 4)
* Life expectancy \< 12 months
* Patient unavailable for follow-up (e.g. no fixed address)
* Pregnant or breast-feeding woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00120003
Study Brief:
Protocol Section:
NCT00120003