PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Condition: Stroke
MeSH terms: Stroke
Intervention: Aggrenox; Aggrenox; Clopidogrel placebo; Clopidogrel placebo; Micardis; Micardis; Aggrenox placebo; Aggrenox placebo; Clopidogrel; Clopidogrel; Micardis placebo; Micardis placebo
Intervention description: 25mg aspirin, 200 mg dipyridamole; 25mg aspirin, 200 mg dipyridamole; placebo; placebo; 80 mg micardis; 80 mg micardis; placebo; placebo; 75 mg clopidogrel; 75 mg clopidogrel; placebo; placebo
Intervention MeSH terms: Telmisartan; Clopidogrel; Aspirin, Dipyridamole Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 20332.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.