PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
- Conditions
- Stroke
- Interventions
- Registration Number
- NCT00153062
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20332
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aggrenox plcebo, clop, micardis placebo Micardis placebo Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd. Aggrenox, Clopidogrel placebo, Micardis Clopidogrel placebo Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd Aggrenox, Clopidogrel placebo, Micardis Micardis Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd Aggrenox placebo, clopidogrel,, Micardis Micardis Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd Aggrenox placebo, clopidogrel,, Micardis Aggrenox placebo Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd Aggrenox, clop placebo, micardis placebo Clopidogrel placebo Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd Aggrenox, clop placebo, micardis placebo Micardis placebo Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd Aggrenox plcebo, clop, micardis placebo Aggrenox placebo Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd. Aggrenox, Clopidogrel placebo, Micardis Aggrenox Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd Aggrenox placebo, clopidogrel,, Micardis Clopidogrel Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd Aggrenox, clop placebo, micardis placebo Aggrenox Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd Aggrenox plcebo, clop, micardis placebo Clopidogrel Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
- Primary Outcome Measures
Name Time Method Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) time since randomization; follow-up period is 1.5 to 4.4 years Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) time since randomization; follow-up period is 1.5 to 4.4 years
- Secondary Outcome Measures
Name Time Method Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) time since randomization; follow-up period is 1.5 to 4.4 years Number of patients with any of stroke, myocardial infarction, vascular death
Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) time since randomization; follow-up period is 1.5 to 4.4 years Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) Randomization to final patient contact
Trial Locations
- Locations (667)
9.159.1101 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
9.159.1173 Boehringer Ingelheim Investigational Site
🇺🇸Huntsville, Alabama, United States
9.159.1058 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
9.159.1087 Boehringer Ingelheim Investigational Site
🇺🇸Montgomery, Alabama, United States
9.159.1081 Boehringer Ingelheim Investigational Site
🇺🇸Northport, Alabama, United States
9.159.1022 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
9.159.1133 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
9.159.1149 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
9.159.1137 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
9.159.1184 Boehringer Ingelheim Investigational Site
🇺🇸Fayetteville, Arkansas, United States
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