PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
The purpose of the trial is to determine if extended-release dipyridamole + aspirin
 [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis,
 Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to
 placebo, in the presence of background antihypertensive therapy, in prevention of a second
 stroke in patients who have recently suffered a stroke and therefore are at high risk of
 suffering another one.
Inclusion criteria:

 Male or female subjects 55 year or older who have suffered an ischemic stroke within the
 past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 -
 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at
 least two of the following additional risk factors:

 -  Diabetes mellitus

 -  Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)

 -  Smoker at time of qualifying stroke

 -  Obesity (BMI>30; BMI=weight (kg)/[height (m)]2)

 -  Previous vascular disease (stroke, MI, or peripheral arterial disease prior to
 qualifying stroke)

 -  End-organ-damage (retinopathy, LVH, or microalbuminuria)

 -  Hyperlipidemia

 Exclusion criteria:

 hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known
 brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease,
 severe coronary artery disease including unstable angina pectoris or an MI within the
 previous 3 months,or history of a hemostatic disorder or systemic bleeding
 ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of
 dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or
 cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs
 are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not
 able or willing to switch to alternative; required or planned continuing treatment with
 antithrombotics or anticoagulants including heparin or warfarin or non-study platelet
 inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery,
 carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely
 to be released from hospital following the qualifying stroke or presence of a severe
 disability likely to lead to being bedridden or demented or a non-vascular disease or
 condition which makes it unlikely that the patient will survive to the end of the trial;
 history of thrombocytopenia or neutropenia.