Description:

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00153062

Link:

http://clinicaltrials.gov/ct2/show/record/NCT00153062

Keywords:
Versions (4) ▾
  1. 11/24/11
  2. 4/13/14
  3. 8/11/14
  4. 8/11/14
Uploaded on:

August 11, 2014

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00153062 Stroke

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
50 Years and older
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 blood pressure (BP)>=140 millimeters of Mercury (mmHg) or diastolic BP>=90mmHg), Smoker at time of qualifying stroke, Obesity (Body mass index (BMI)>30, BMI=weight in kilograms (kg)/[height in meters (m)]2), Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke), End-organ-damage (retinopathy, left ventricular hypertrophy (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 blood pressures are lower)
Systolic blood pressure (SBP) 120 mmHg or less for hospitalized patients. Currently taking an Angiotensin II receptor blocker (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
Medical concepts