PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

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.

Conditions

• Stroke

Interventions

DRUG

Aggrenox

25mg aspirin, 200 mg dipyridamole

DRUG

Aggrenox

25mg aspirin, 200 mg dipyridamole

DRUG

Clopidogrel placebo

placebo

DRUG

Clopidogrel placebo

placebo

DRUG

Micardis

80 mg micardis

DRUG

Micardis

80 mg micardis

DRUG

Aggrenox placebo

placebo

DRUG

Aggrenox placebo

placebo

DRUG

Clopidogrel

75 mg clopidogrel

DRUG

Clopidogrel

75 mg clopidogrel

DRUG

Micardis placebo

placebo

DRUG

Micardis placebo

placebo

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Bayer

  collaborator INDUSTRY

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-08-31

Primary Completion

2008-04-30

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• China
• Denmark
• El Salvador
• Finland
• France
• Germany
• Greece
• Hong Kong
• India
• Ireland
• Israel
• Italy
• Japan
• Malaysia
• Mexico
• Netherlands
• Norway
• Portugal
• Russia
• Singapore
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations