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Status:

COMPLETED

PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Lead Sponsor:

Boehringer Ingelheim

Collaborating Sponsors:

GlaxoSmithKline

Bayer

Conditions:

Stroke

Eligibility:

All Genders

50+ years

Phase:

PHASE4

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, K...

Eligibility Criteria

Inclusion

  • 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:
  • Diabetes mellitus
  • Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
  • Smoker at time of qualifying stroke
  • Obesity (BMI\>30; BMI=weight (kg)/\[height (m)\]2)
  • Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
  • End-organ-damage (retinopathy, LVH, or microalbuminuria)
  • Hyperlipidemia
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    20332 Patients enrolled

    Trial Details

    Trial ID

    NCT00153062

    Start Date

    August 1 2003

    Last Update

    May 13 2014

    Active Locations (667)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 167 (667 locations)

    1

    9.159.1101 Boehringer Ingelheim Investigational Site

    Birmingham, Alabama, United States

    2

    9.159.1173 Boehringer Ingelheim Investigational Site

    Huntsville, Alabama, United States

    3

    9.159.1058 Boehringer Ingelheim Investigational Site

    Mobile, Alabama, United States

    4

    9.159.1087 Boehringer Ingelheim Investigational Site

    Montgomery, Alabama, United States