Phase 4 N=20,332 Randomized Double-blind Prevention

PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT00153062 ↗

Enrolled (actual)

20,332

Serious AEs

—

Results posted

Sep 2009

Primary outcome: Primary: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) — 916; 898 Participants — p=0.7830

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aggrenox (Drug); Clopidogrel placebo (Drug); Micardis (Drug); Aggrenox placebo (Drug); Clopidogrel (Drug); Micardis placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)	916; 898	0.7830
PRIMARY Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)	880; 934	0.2312
SECONDARY Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)	1333; 1333	0.8292
SECONDARY Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)	1367; 1463	0.1073
SECONDARY Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)	125; 151	0.1007

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00153062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.