PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Official Title: “PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis”

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.

Intervention(s) in this Clinical Trial

• Drug: extended-release dipyridamole + aspirin
• Drug: clopidogrel
• Drug: telmisartan

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: ASA+ERDP / Telmisartan
• Experimental: ASA+ERDP / Placebo
• Active Comparator: Clopidogrel / Telmisartan
• Active Comparator: Clopidogrel / Placebo

Primary Measures

• Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
  • Time Frame: 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 Frame: time since randomization; follow-up period is 1.5 to 4.4 years
    

Secondary Measures

• Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
  • Time Frame: time since randomization; follow-up period is 1.5 to 4.4 years
    
• Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
  • Time Frame: time since randomization; follow-up period is 1.5 to 4.4 years
    
• Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
  • Time Frame: Randomization to final patient contact
    

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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00153062

Study ID Number: 9.159

ClinicalTrials.gov Identifier: NCT00153062

Health Authority: Argentina: Ministry of Health