Individuals with transient ischemic attack and ischemic stroke are at a high risk of recurrent stroke and death. Elevated blood pressure is the strongest risk factor for stroke and lowering of blood pressure reduces this risk.

Treatments that block the renin-angiotensin-aldosterone system (RAAS) may prove effective in patients at risk or high risk for stroke or secondary stroke. Activation of the RAAS has been linked with hypertension and is known to exert a wide variety of deleterious effects that can hasten end-organ damage.

Angiotensin II receptor blockers (ARBs) reduce blood pressure by interrupting the RAAS. Clinical and non-clinical studies show that ARBs reduce factors associated with increased risk of stroke.

In addition to its effects on blood pressure, angiotensin II exerts a wide variety of deleterious effects on target organs that can hasten end-organ damage. Interventions that target the RAAS may have benefits in addition to their effects on hypertension.

The PRoFESS™ trial addressed key therapeutic issues for stroke patients and their physicians with an investigation of the potential of telmisartan for cerebrovascular protection telmisartan in addition to standard stroke prevention therapy. It also included a head-to-head comparison of aspirin and dipyridamole vs. clopidogrel in reducing the risk of secondary stroke.

Two primary analyses:

• Telmisartan added to standard antiplatelet therapy versus standard antiplatelet therapy alone


• ER-DP + ASA compared with clopidogrel

Patients:

• Age ≥55 years AND ischaemic stroke within 90 days prior to study entry

OR

• Age >50 years AND ischaemic stroke within 120 days prior to study entry AND at least two risk factors: Diabetes mellitus, hypertensive, smoker at time of qualifying stroke, obese, vascular damage (stroke, myocardial infarction, or peripheral artery disease) prior to qualifying stroke, end-organ damage (retinopathy, left-ventricular hypertrophy or microalbuminuria)

Blood pressure was controlled with a diuretic, beta-blocker and/or calcium channel blocker as needed.

Follow-up:

• Baseline visit and on discharge from hospital or day 7


• Visits at month 1, month 3 and month 6


• Visits every 6 months thereafter


• Telephone contact every 3 months


• Treatment period up to 4 years