Elevated Blood Pressure in the Acute Phase of Stroke and the Role of Angiotensin Receptor Blockers

Table 2

Main characteristics of the included trials.

Study	ACCESS [27]	PRoFESS [28]*	SCATS [29]
Main inclusion criteria	Motor deficit, cerebral CT scan excluding intracranial hemorrhage, onset of symptoms within 72 hours, necessity to treat hypertension according to current recommendations^#.	Ischemic stroke within 72 hours from onset of symptoms, age older than 55 years or age 50–54 years if 2 additional vascular risk factors present, seated systolic BP 121 to 180 mmHg, seated diastolic BP ≥110 mmHg, neurological and clinical stability.	Patients aged 18 years or older with a clinical diagnosis of stroke (ischaemic or haemorrhagic), presenting within 30 hours of symptom onset and with systolic BP higher than 140 mmHg.
Relevant exclusion criteria	Age ≥85 years, occlusion or ≥70% stenosis of the internal carotid artery, malignant hypertension, manifest cardiac failure (NYHA class III and IV), high-grade aortic or mitral stenosis, unstable angina pectoris, contraindications against candesartan cilexetil.	Dysphagia preventing oral medication, mRS >3 at time of randomization, severe known renal insufficiency or renal artery stenosis or coronary artery disease or recent MI, hyperkalemia, uncorrected volume or sodium depletion, schedule for carotid endarterectomy, currently using or needing ARB	SSS consciousness score ≤2, premorbid mRS ≥4, clear indication for or contraindications to or current treatment with an ARB.
Treatment design	Candesartan cilexetil (4–16 mg daily according to BP levels)^+.	Telmisartan (80 mg daily).	Candesartan cilexetil (4 mg on day 1, 8 mg on day 2 and 16 mg on days 3–7)^†.
Follow-up evaluation	On day 7, at 3, 6, and 12 months.	On day 7, at 1, and 3 months.	On day 7, at 1, and 6 months.
Primary endpoints	Case fatality and disability (measured as BI) at 3 months.	Combined death or dependency (measured as mRS) at 30 days.	Composite endpoint of vascular death, nonfatal MI or nonfatal stroke and functional status (measured as mRS) at 6 months.
Secondary endpoints	Overall mortality and cerebrovascular and cardiovascular events at 12 months.	Overall mortality and cerebrovascular and cardiovascular events at 7, 30, and 90 days.	Stroke progression^‡; neurological status at 7 days (measured as SSS); overall mortality, cerebrovascular and cardiovascular events, functional outcome (measured as BI) at 6 months.

∗In the PRoFESS trial a subgroup analysis has been considered.
^#This was assumed when the mean of at least 2 blood pressure measurements was ≥200 mmHg systolic and/or ≥110 mmHg diastolic 6 to 24 hours after admission or ≥180 mmHg systolic and/or ≥105 mmHg diastolic 24 to 36 hours after admission.
⁺Candesartan cilexetil 4 mg daily on day 1; on day 2, dosage was increased to 8 or 16 mg if blood pressure exceeded 160 mmHg systolic or 100 mmHg diastolic. At the end of the placebo-controlled 7-days phase, in candesartan cilexetil-treated patients the dosage was increased or an additional antihypertensive drug was added only in the case of a hypertensive profile (mean daytime blood pressure ≥135/85 mm Hg). In placebo-treated patients candesartan cilexetil was started only in presence of a hypertensive profile.
^†Dose adjustments were made if systolic blood pressure was lower than 120 mmHg or when clinically indicated.
^‡Stroke progression was defined as a neurological deterioration of 2 or more points on the SSS occurring within the first 72 h of stroke onset and believed to be caused by the index stroke, after exclusion of recurrent stroke or systemic reasons for deterioration.
ARB: angiotensin receptor blocker; BI: barthel index; BP: blood pressure; MI: myocardial infarction; mRS: modified ranking scale; NYHA: New York Heart Association; SSS: Scandinavian stroke scale.