PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Completed · Phase 4 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00153062

Run by

Boehringer Ingelheim

People needed

20332

Starts

2003-08-01

Last updated by the study team

2014-05-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 9.159.1173 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 9.159.1058 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 9.159.1087 Boehringer Ingelheim Investigational Site — Montgomery, Alabama, United States
• 9.159.1081 Boehringer Ingelheim Investigational Site — Northport, Alabama, United States
• 9.159.1022 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 9.159.1133 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 9.159.1149 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 9.159.1137 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 9.159.1184 Boehringer Ingelheim Investigational Site — Fayetteville, Arkansas, United States
• 9.159.1005 Boehringer Ingelheim Investigational Site — Fort Smith, Arkansas, United States
• 9.159.1136 Boehringer Ingelheim Investigational Site — Jonesboro, Arkansas, United States
• 9.159.1062 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 9.159.1040 Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• 9.159.1180 Boehringer Ingelheim Investigational Site — Carmichael, California, United States
• 9.159.1114 Boehringer Ingelheim Investigational Site — Irvine, California, United States
• 9.159.1202 Boehringer Ingelheim Investigational Site — Laguna Hills, California, United States
• 9.159.1036 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 9.159.1052 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 9.159.1100 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 9.159.1111 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 9.159.1165 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 9.159.1134 Boehringer Ingelheim Investigational Site — Oceanside, California, United States
• 9.159.1002 Boehringer Ingelheim Investigational Site — Palo Alto, California, United States
• 9.159.1108 Boehringer Ingelheim Investigational Site — Redding, California, United States
• 9.159.1101 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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