PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Aggrenox; Drug: Clopidogrel placebo; Drug: Aggrenox placebo; Drug: Micardis placebo; Drug: Micardis; Drug: Clopidogrel

• 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

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2008-04
• Results First Submitted: 2009-02-06
• Results First Submitted QC: 2009-07-22
• Results First Posted: 2009-09-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-05-13

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

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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