PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Stroke

About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- 9.159.1101 Boehringer Ingelheim Investigational Site
- 9.159.1173 Boehringer Ingelheim Investigational Site
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- 9.159.1026 University of Illinois
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- 9.159.1129 Central Baptis Hospital
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- 9.159.1128 St. Luke's Hospital MABSI Research
- 9.159.1172 Boehringer Ingelheim Investigational Site
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- 9.159.1042 Neurology Consultants of Burlington County
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- 9.159.1076 North Shore University Hospital
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- 9.159.1142 Saint Luke's-Roosevelt Hospital
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- 9.159.1098 Community Healthcare Clinic Westhill Medical Specialists
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- 9.159.1551 Boehringer Ingelheim Investigational Site
- 9.159.2869 Complexo Hospitalar Universitario Prof Edgard Santos
- 9.159.2853 Boehringer Ingelheim Investigational Site
- 9.159.1397 Foothills Medical Centre
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- 9.159.1381 Ottawa Hospital General Campus
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- 9.159.2729 Barzilai Medical Center
- 9.159.2721 Neurology Unit
- 9.159.2724 Rambam Medical Center, Tel-Aviv Medical
- 9.159.2723 Boehringer Ingelheim Investigational Site
- 9.159.2727 Western Galilee Hospital
- 9.159.2722 Neurology Unit
- 9.159.2726 Sheba Medical Center
- 9.159.2725 Tel Aviv Medical Center
- 9.159.1875 Università degli Studi di Ancona
- 9.159.1882 Ospedale Brotzu
- 9.159.1883 Azienda Ospedaliera S. Anna
- 9.159.1871 Azienda Ospedaliera "Careggi"
- 9.159.1869 Università degli Studi di Genova
- 9.159.1870 ASL No. 5 di Jesi
- 9.159.1865 Ospedale Regionale "S. Salvatore"
- 9.159.1866 Ospedale S. Raffaele
- 9.159.1873 Istituto Scientifico "S. Luca"
- 9.159.1884 Ospedale S. Carlo Borromeo"
- 9.159.1868 Ospedale "S. Maria di Loreto Mare"
- 9.159.1876 Azienda Ospedaliera di Padova -Policlinico Universitario
- 9.159.1874 Ospedale Civico - ARNAS
- 9.159.1872 Neuromed IRCCS
- 9.159.1879 Policlinico S. Andrea
- 9.159.1881 Università "La Sapienza"
- 9.159.1877 Azienda Ospedaliera Umberto I
- 9.159.1878 Azienda Ospedaliera "Santo Maria"
- 9.159.1864 Azienda Ospedaliera "S. Giovanni Battista"
- 9.159.1863 Ospedale di Cattinara
- 9.159.1867 Presidio Ospedaliero G.Jazzolino
- 9.159.1880 Ospedale Civile
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- 9.159.2951 Boehringer Ingelheim Investigational Site
- 9.159.2959 Boehringer Ingelheim Investigational Site
- 9.159.2944 Boehringer Ingelheim Investigational Site
- 9.159.2947 Boehringer Ingelheim Investigational Site
- 9.159.2954 Boehringer Ingelheim Investigational Site
- 9.159.2942 Boehringer Ingelheim Investigational Site
- 9.159.2948 Boehringer Ingelheim Investigational Site
- 9.159.2957 Boehringer Ingelheim Investigational Site
- 9.159.2940 Boehringer Ingelheim Investigational Site
- 9.159.2973 Boehringer Ingelheim Investigational Site
- 9.159.2949 Boehringer Ingelheim Investigational Site
- 9.159.2953 Boehringer Ingelheim Investigational Site
- 9.159.2943 Boehringer Ingelheim Investigational Site
- 9.159.2963 Boehringer Ingelheim Investigational Site
- 9.159.2933 Boehringer Ingelheim Investigational Site
- 9.159.2955 Boehringer Ingelheim Investigational Site
- 9.159.2938 Boehringer Ingelheim Investigational Site
- 9.159.2967 Boehringer Ingelheim Investigational Site
- 9.159.2969 Boehringer Ingelheim Investigational Site
- 9.159.2952 Boehringer Ingelheim Investigational Site
- 9.159.2961 Boehringer Ingelheim Investigational Site
- 9.159.2934 Boehringer Ingelheim Investigational Site
- 9.159.2971 Boehringer Ingelheim Investigational Site
- 9.159.2962 Boehringer Ingelheim Investigational Site
- 9.159.2939 Boehringer Ingelheim Investigational Site
- 9.159.2956 Boehringer Ingelheim Investigational Site
- 9.159.2941 Boehringer Ingelheim Investigational Site
- 9.159.2945 Boehringer Ingelheim Investigational Site
- 9.159.2937 Boehringer Ingelheim Investigational Site
- 9.159.2966 Boehringer Ingelheim Investigational Site
- 9.159.2936 Boehringer Ingelheim Investigational Site
- 9.159.2946 Boehringer Ingelheim Investigational Site
- 9.159.2935 Boehringer Ingelheim Investigational Site
- 9.159.2950 Boehringer Ingelheim Investigational Site
- 9.159.2972 Boehringer Ingelheim Investigational Site
- 9.159.1593 Boehringer Ingelheim Investigational Site
- 9.159.1595 Boehringer Ingelheim Investigational Site
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- 9.159.2707 Boehringer Ingelheim Investigational Site
- 9.159.2706 Boehringer Ingelheim Investigational Site
- 9.159.2765 Boehringer Ingelheim Investigational Site
- 9.159.1960 Jeroen Bosch Ziekenhuis
- 9.159.1945 Medisch Centrum Alkmaar
- 9.159.1963 Polikliniek Neurologie
- 9.159.1949 Ziekenhuis Gooi-Noord
- 9.159.1962 Locatie Molengracht
- 9.159.1950 HagaZiekenhuis
- 9.159.1959 Catharina Ziekenhuis
- 9.159.1946 Scheper Ziekenhuis
- 9.159.1958 Medisch Spectrum Twente
- 9.159.1943 Umcg
- 9.159.1961 Lokatie Van Swieten
- 9.159.1953 Atrium Medisch Centrum
- 9.159.1955 Elkerliek Ziekenhuis
- 9.159.1951 Ziekenhuisgroep Twente
- 9.159.1948 Medisch Centrum Leeuwarden
- 9.159.1952 Rijnland Ziekenhuis
- 9.159.1947 Sint Antonius Ziekenhuis
- 9.159.1964 Canisius-Wilhelmina ziekenhuis
- 9.159.1956 TweeSteden Ziekenhuis Tilburg
- 9.159.1957 Sint Elisabeth Ziekenhuis
- 9.159.1944 Máxima Medisch Centrum
- 9.159.1954 St. Jans Gasthuis
- 9.159.2029 Boehringer Ingelheim Investigational Site
- 9.159.2028 Boehringer Ingelheim Investigational Site
- 9.159.2027 Boehringer Ingelheim Investigational Site
- 9.159.2040 Hospital Fernando Fonseca
- 9.159.2039 Centro Hospitalar e Universitário de Coimbra, EPE
- 9.159.2041 Centro Hospitalar de Lisboa Norte
- 9.159.2042 Centro Hospitalar do Porto
- 9.159.2114 Boehringer Ingelheim Investigational Site
- 9.159.2102 Boehringer Ingelheim Investigational Site
- 9.159.2117 Boehringer Ingelheim Investigational Site
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- 9.159.2079 Boehringer Ingelheim Investigational Site
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- 9.159.2084 Boehringer Ingelheim Investigational Site
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- 9.159.2087 Boehringer Ingelheim Investigational Site
- 9.159.2088 Boehringer Ingelheim Investigational Site
- 9.159.2089 Boehringer Ingelheim Investigational Site
- 9.159.2090 Boehringer Ingelheim Investigational Site
- 9.159.2091 Boehringer Ingelheim Investigational Site
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- 9.159.2093 Boehringer Ingelheim Investigational Site
- 9.159.2095 Boehringer Ingelheim Investigational Site
- 9.159.2098 Boehringer Ingelheim Investigational Site
- 9.159.2101 Boehringer Ingelheim Investigational Site
- 9.159.2105 Boehringer Ingelheim Investigational Site
- 9.159.2115 Boehringer Ingelheim Investigational Site
- 9.159.2119 Boehringer Ingelheim Investigational Site
- 9.159.2111 Boehringer Ingelheim Investigational Site
- 9.159.2106 Boehringer Ingelheim Investigational Site
- 9.159.2108 Boehringer Ingelheim Investigational Site
- 9.159.2109 Boehringer Ingelheim Investigational Site
- 9.159.2110 Boehringer Ingelheim Investigational Site
- 9.159.2118 Boehringer Ingelheim Investigational Site
- 9.159.2086 Boehringer Ingelheim Investigational Site
- 9.159.2094 Boehringer Ingelheim Investigational Site
- 9.159.2097 Boehringer Ingelheim Investigational Site
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- 9.159.2120 Boehringer Ingelheim Investigational Site
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- 9.159.2113 Boehringer Ingelheim Investigational Site
- 9.159.2104 Boehringer Ingelheim Investigational Site
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- 9.159.2703 Boehringer Ingelheim Investigational Site
- 9.159.2704 Boehringer Ingelheim Investigational Site
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- 9.159.2060 Boehringer Ingelheim Investigational Site
- 9.159.2056 Boehringer Ingelheim Investigational Site
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- 9.159.2055 Boehringer Ingelheim Investigational Site
- 9.159.2061 Boehringer Ingelheim Investigational Site
- 9.159.2058 Boehringer Ingelheim Investigational Site
- 9.159.2059 Boehringer Ingelheim Investigational Site
- 9.159.2179 Boehringer Ingelheim Investigational Site
- 9.159.2177 Boehringer Ingelheim Investigational Site
- 9.159.2178 Boehringer Ingelheim Investigational Site
- 9.159.2175 Boehringer Ingelheim Investigational Site
- 9.159.2176 Boehringer Ingelheim Investigational Site
- 9.159.2180 Boehringer Ingelheim Investigational Site
- 9.159.2223 Boehringer Ingelheim Investigational Site
- 9.159.2209 Boehringer Ingelheim Investigational Site
- 9.159.2204 Boehringer Ingelheim Investigational Site
- 9.159.2205 Boehringer Ingelheim Investigational Site
- 9.159.2728 Neurology Unit
- 9.159.2210 Boehringer Ingelheim Investigational Site
- 9.159.2206 Boehringer Ingelheim Investigational Site
- 9.159.2211 Boehringer Ingelheim Investigational Site
- 9.159.2216 Boehringer Ingelheim Investigational Site
- 9.159.2215 Boehringer Ingelheim Investigational Site
- 9.159.2203 Boehringer Ingelheim Investigational Site
- 9.159.2212 Boehringer Ingelheim Investigational Site
- 9.159.2213 Boehringer Ingelheim Investigational Site
- 9.159.2222 Boehringer Ingelheim Investigational Site
- 9.159.2225 Boehringer Ingelheim Investigational Site
- 9.159.2207 Boehringer Ingelheim Investigational Site
- 9.159.2214 Boehringer Ingelheim Investigational Site
- 9.159.2224 Boehringer Ingelheim Investigational Site
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- 9.159.2251 Boehringer Ingelheim Investigational Site
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- 9.159.2254 Boehringer Ingelheim Investigational Site
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- 9.159.2797 Boehringer Ingelheim Investigational Site
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- 9.159.2827 Boehringer Ingelheim Investigational Site
- 9.159.2825 Boehringer Ingelheim Investigational Site
- 9.159.2826 Boehringer Ingelheim Investigational Site
- 9.159.2828 Dkuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.
- 9.159.2387 Boehringer Ingelheim Investigational Site
- 9.159.2384 Boehringer Ingelheim Investigational Site
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- 9.159.2304 Boehringer Ingelheim Investigational Site
- 9.159.2297 Boehringer Ingelheim Investigational Site
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- 9.159.2296 Boehringer Ingelheim Investigational Site
- 9.159.2300 Boehringer Ingelheim Investigational Site
- 9.159.2287 Boehringer Ingelheim Investigational Site
- 9.159.2303 Boehringer Ingelheim Investigational Site
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- 9.159.2286 Boehringer Ingelheim Investigational Site
- 9.159.2293 Boehringer Ingelheim Investigational Site
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- 9.159.2305 Boehringer Ingelheim Investigational Site
- 9.159.2290 Boehringer Ingelheim Investigational Site
- 9.159.2288 Boehringer Ingelheim Investigational Site
- 9.159.2285 Boehringer Ingelheim Investigational Site
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- 9.159.2292 Boehringer Ingelheim Investigational Site
- 9.159.2289 Boehringer Ingelheim Investigational Site
- 9.159.2306 Boehringer Ingelheim Investigational Site
- 9.159.2291 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Aggrenox, Clopidogrel placebo, Micardis
Aggrenox placebo, clopidogrel,, Micardis
Aggrenox, clop placebo, micardis placebo
Aggrenox plcebo, clop, micardis placebo
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.