PRoFESS, the largest-ever secondary stroke prevention trial, will include a total of 15,500 patients in about 600 sites in more than 20 countries.
The principal investigator, Prof. Hans-Christoph Diener, randomized the first patient at the University of Essen in Germany.
At the Vienna Congress, leading experts in the cardiovascular field presented the 2x2 factorial design of the trial. PRoFESS aims to show the secondary stroke prevention potential of dipyridamole and telmisartan.
The trial is comparing extended release dipyridamole plus low-dose aspirin (ASA) with clopidogrel + ASA, and telmisartan with placebo in the prevention of recurrent stroke.
PRoFESS complements the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET) and the Program of Research to show Telmisartan End-organ proteCTION (PROTECTION) trial programs. Both are sponsored by Boehringer Ingelheim.
With these clinical trials involving vascular endpoints, the company is conducting one of the most comprehensive cardio- and cerebrovascular protection programs.
"We are delighted about the interest that PRoFESS raises in the scientific community, even before 2007, when we expect the results," said Dr. Barner, a member of the Boehringer Ingelheim board of managing directors.
"PRoFESS is testing one of the most burning clinical questions: Which antiplatelet regimen to use to prevent a recurrent stroke and the idea of simultaneously investigating the efficacy of an ARB in early and late stroke prevention," Diener said.
The main risk for a second stroke is a prior stroke due to degenerative processes in the wall of blood vessels supplying the brain. Patients at high risk of a second stroke will readily seek preventive treatment. The vascular pathobiology of ischaemic stroke is multiple, and antithrombotic mechanisms in the cerebro-vascular microenvironment beyond platelet inhibition are now being considered as providing additional means of reducing ischaemic stroke. PRoFESS is expected to demonstrate this.
The multiple mechanisms of action of dipyridamole + ASA in the cerebrovascular environment now emerging in experimental studies may account for the known clinical outcome in previous trials.
Dipyridamole + ASA has been shown to be twice as effective for secondary stroke prevention as either ASA or dipyridamole alone. This suggests superior antithrombotic effect for combination therapy.
Since angiotensin II is a molecule involved in many developmental stages of cerebro- and cardiovascular diseases, an angiotensin II receptor blocker (ARB) such as telmisartan can affect cardiovascular morbidity and mortality.
Telmisartan may further reduce the risk of recurrent stroke by blocking angiotensin II which has direct effects on blood pressure and target organ damage.
Telmisartan distinguishes itself among the other ARBs with its long half-life and 24-hour duration of action, especially during the high-risk early morning hours. In the morning, patients are at highest risk of a cardiovascular event such as stroke.
The comprehensive Boehringer Ingelheim online information platform on cerebro- and cardiovascular protection is accessible for physicians only at:
• www.micardis.com
Launched at the ESC 2003, it provides information on the product and its unique clinical trial program, daily cardiology news and auxiliary tools such as the Braunwald Atlas of Hypertension.
• www.ontarget.micardis.com
Provides information on the ONTARGET trial program, its scientific rationale and progress, and a conference calendar.
• www.profess-study.com
Provides information on the PRoFESS trial, its design, scientific rationale and progress, and virtual symposia.