PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
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:
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.
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Worchester, Massachusetts, United States
Lees Summit, Missouri, United States
Manasset, New York, United States
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Rosario, Santa Fe, Argentina
West Heidelberg, Victoria, Australia
Ma.Gugging/Klosterneuburg, Austria
Xian, Shanxi, China
Aarhuc C, Denmark
Oviedo, El Salvador
Bad Neustadt/Saale, Germany
Israel, Israel
Akashi, Hyogo, Japan
Akashi, Hyogo, Japan
Ako, Hyogo, Japan
Aoba-ku, Yokohama, Kanagawa, Japan
Azumino, Nagano, Japan
Chuo-ku, Kobe, Hyogo, Japan
Chuo-Ku, Sapporo, Hokkaido, Japan
Fushimi-ku, Kyoto, Kyoto, Japan
Habikino, Osaka, Japan
Higashi-ku, Sapporo, Hokkaido, Japan
Higashi-osaka, Osaka, Japan
Higashinari-ku, Osaka, Osaka, Japan
Higashiyodogawa-ku, Osaka, Osaka, Japan
Hitachinaka, Ibaraki, Japan
Iida, Nagano, Japan
Izumisano, Osaka, Japan
Jyonan-ku, Fukuoka, Fukuoka, Japan
Kasama, Ibaraki, Japan
Kasuga, Fukuoka, Japan
Kita-ku, Osaka, Osaka, Japan
Koriyama, Fukushima, Japan
Matsumoto, Nagano, Japan
Midori-ku, Yokohama, Kanagawa, Japan
Moriya, Ibaraki, Japan
Musashino, Tokyo, Japan
Nakagawa-ku, Nagoya, Aichi, Japan
Nishi-yodogawa-ku, Osaka, Osaka, Japan
Sakai-ku, Sakai, Osaka, Japan
Sawara-ku, Fukuoka, Fukuoka, Japan
Shimogyo-ku, Kyoto, Kyoto, Japan
Shiroishi, Miyagi, Japan
Suwa, Nagano, Japan
Tsuchiura, Ibaraki, Japan
Yao, Osaka, Japan
Kelantan Darul Naim, Malaysia
Nizhnyi Novgorod, Russia
Kyunggi-do, South Korea
Holon, Sweden
Vinnytzya, Ukraine