PRoFESS ® Trial

PRoFESS® Trial Prevention Regimen For Effectively avoiding Second Strokes (PRoFESS®)

PRoFESS® Trial PRoFESS® Trial Presented at the 17th European Stroke Conference (ESC) in Nice, France Presented by Dr. Ralph Sacco, Dr. Salim Yusuf, Dr. Hans-Christof Diener Copyleft Clinical Trial Results. You Must Redistribute Slides

PRoFESS® Trial: Background • Elevated blood pressure is a significant risk factor for stroke and recurrent stroke. • The ESP2 trial showed that extended-release dipyridamle (ER-DP) + Aspirin combination therapy is beneficial in the reduction of secondary strokes. • The PRoFESS® trial aimed to 1) show that aspirin combined with ER-DP is superior to Clopidogrel in preventing stroke recurrence and 2) evaluate the relationship between blood pressure lowering and stroke recurrence via treatment with Telmisartan vs. placebo. Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Study Design 20,332 patients > 50 years with at least ischemic stroke* (see inclusion criteria) Double-blind. Placebo-controlled. Simultaneous randomization. Doses: (200 mg ER-DP + 25 mg Aspirin) 2x/day, 80 mg Telmisartan, 75 mg Clopidogrel 1x/day R ER-DP + Aspirin + Telmisartan n= 5,000 Clopidogrel + Telmisartan n= 5,000 ER-DP + Aspirin + Placebo n=5,000 Clopidogrel + Placebo n=5,000 2.5 yrs. mean follow-up • Primary Endpoint: rate of first recurrent stroke • Secondary Endpoints: stroke, MI, vascular death, rate of new diabetes mellitus • Tertiary Endpoints: major hemorrhagic event, all deaths, new or worsening congestive heart failure Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Inclusion Criteria Age ≥ 55 years and ischemic stroke within 90 days prior to study entry Age 50-54 years and/or 90-120 with stroke and at least 2 of the following risk factors: Vascular disease (stroke, MI, or peripheral artery disease) prior to qualifying stroke Hypertension (SBP ≥ 140 or DBP ≥ 90 mm Hg) Diabetes mellitus Obesity (BMI > 30) Smoker at time of qualifying stroke End-organ damage (retinopathy, left-ventricular hypertrophy, or microalbuminuria) Neurologically and clinically stable Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Exclusion Criteria Hemorrhagic stroke Congestive heart failure or unstable angina Pre-stroke history of dementia requiring institutional care Inability to give informed consent Modified Rankin Scale > 4 Hypersensitivity to any of the study drugs Hepatic and renal insufficiency History of thrombocytopenia Uncontrolled hypertension or ongoing treatment with an ARB Required or planned continued treatment with antithrombotics or anticoagulants Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Baseline Characteristics Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Baseline Characteristics *n = 20,332 for all baseline values Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Baseline Characteristics Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Primary Endpoint p = 0.783 • The rate of first recurrent stroke was similar between the combination therapy and the single antiplatelet agent treatment groups. • HR 1.01 • 95% CI 0.92-1.11 Stroke recurrence (%) n = 10,000 n = 10,000 Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Primary Endpoint Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Primary Endpoint p = 0.23 • Telmisartan demonstrated no significant benefit over placebo in the rate of recurrent stroke. • Lowering blood pressure with Telmisartan for 2.5 years after a stroke does not significantly reduce the rate of stroke. • HR 0.95 • 95% CI 0.86-1.04 Stroke recurrence (%) n = 10,000 n = 10,000 Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Primary Endpoint Exploratory Analysis • There was no significant difference in the rates of recurrent stroke between the Telmisartan and placebo groups in the first 6 months of the trial. • HR 1.07 • 95% CI 0.92-1.25 p = 0.38 Stroke recurrence (%) n = 10,000 n = 10,000 Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Primary Endpoint Exploratory Analysis p = 0.029 • Beyond 6 months, Telmisartan was associated with a lower stroke recurrence rate. • HR 0.88 • 95% CI 0.78-0.99 Stroke recurrence (%) n = 10,000 n = 10,000 Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Secondary Endpoint p = 0.83 • There was no difference in the rate of secondary endpoint between the two groups. • HR 0.99 • 95% CI 0.92-1.07 Stroke, MI or vascular death (%) n = 10,000 n = 10,000 ER-DP + Aspirin Clopidogrel Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Secondary Endpoint p = 0.11 • There was no significant difference in the occurrence of major vascular events (stroke, MI, vascular death, new or worsening heart failure) between the two groups. • HR 0.94 • 95% CI 0.87-1.01 Major vascular events (%) n = 10,000 n = 10,000 Telmisartan Placebo Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Secondary Endpoint • There was no significant difference in the rate of new diabetes mellitus between the two groups. • HR 0.82 • 95% CI 0.65-1.04 p = 0.10 Rate of new diabetes mellitus (%) n = 10,000 n = 10,000 Telmisartan Placebo Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Secondary Endpoint Exploratory Analysis p = 0.14 • There was no significant difference in the occurrence of major vascular events between the two groups during the first 6 months of the the trial. • HR 1.10 • 95% CI 0.97-1.26 Rate of major vascular event (%) n = 10,000 n = 10,000 Telmisartan Placebo Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Secondary Endpoint Exploratory Analysis p = 0.0029 • Beyond 6 months, the rate of major vascular events was lower in the Telmisartan group. • HR 0.87 • 95% CI 0.80-0.95 Rate of major vascular event (%) n = 10,000 n = 10,000 Telmisartan Placebo Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: 2º and 3º Outcomes Copyleft Clinical Trial Results. You Must Redistribute Slides Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Benefit/Risk Analysis p = 0.50 • There was no significant difference in the benefit-risk ratio between the two groups. • HR 1.03 • 95% CI 0.95-1.11 Stroke recurrence or major hemorrhage (%) n = 10,000 n = 10,000 ER-DP + Aspirin Clopidogrel Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS®Trial: Limitations The duration of follow up should be extended for an accurate assessment of the long term effects of both the blood pressure lowering and antiplatelet therapies on the rate of recurrent stroke. Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS® Trial: Summary • ER-DP/Aspirin combination therapy is not superior to Clopidogrel in reducing stroke recurrence rate. • Lowering blood pressure for 2.5 years after a stroke does not significantly reduce the rate of recurrent stroke or other major vascular events compared to placebo. Cerebrovascular Dis. 2007; 23/ESC 2008

PRoFESS ® Trial

PRoFESS ® Trial

Presentation Transcript

After a Stroke

Avoiding The Quick Fix

How To Partner Effectively With Faith-based Organizations

Foundations of Prevention

Opinion mining, sentiment analysis, and beyond

Psychological Disorders and Therapy

Strokes in the Elderly

Outline:

Clinical Presentation of Stroke Syndromes

BRUSH STROKES

Tabla Strokes Recognition

Regimen Selection to Support a “Public Health” Approach

A Blueprint to Avoiding Collisions

Flocking Strokes

Preventing Strokes One at a Time Putting It All Together

Welcome to Metonga Lake!