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PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Aggrenox plcebo, clop, micardis placeboMicardis placeboClopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
Aggrenox, Clopidogrel placebo, MicardisClopidogrel placeboAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
Aggrenox, Clopidogrel placebo, MicardisMicardisAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
Aggrenox placebo, clopidogrel,, MicardisMicardisClopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
Aggrenox placebo, clopidogrel,, MicardisAggrenox placeboClopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
Aggrenox, clop placebo, micardis placeboClopidogrel placeboAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
Aggrenox, clop placebo, micardis placeboMicardis placeboAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
Aggrenox plcebo, clop, micardis placeboAggrenox placeboClopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
Aggrenox, Clopidogrel placebo, MicardisAggrenoxAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
Aggrenox placebo, clopidogrel,, MicardisClopidogrelClopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
Aggrenox, clop placebo, micardis placeboAggrenoxAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
Aggrenox plcebo, clop, micardis placeboClopidogrelClopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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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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9.159.1101 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States

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