Largest-Ever Secondary Stroke Prevention Trial Completes Recruitment

Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials
Article Date: 27 Oct 2006 - 0:00 PDT

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Dipyridamole and Acetylsalicylic Acid (ASA) With Clopidogrel Patient recruitment to the world's largest secondary stroke prevention study PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes), is now complete. Baseline data on the 20,333 patients recruited to the study from 720 sites in 35 countries were presented today at the Joint World Congress on Stroke in Cape Town, South Africa.[1]

PRoFESS aims to demonstrate that extended release dipyridamole plus ASA[x], marketed by Boehringer Ingelheim as Aggrenox(R) or Asasantin(R)Retard , is superior in preventing secondary strokes compared with clopidogrel. The study will also examine whether Boehringer Ingelheim's telmisartan (Micardis(R)), an angiotensin receptor blocker (ARB), in addition to the usual care in individuals after a stroke, will reduce the risk of further strokes compared with placebo.

"The baseline data of PRoFESS confirm that we have succeeded in enrolling a representative international patient population who have had a stroke. All patients received standard state of the art treatments for stroke prevention," said Professor Ralph L. Sacco, Professor of Neurology and Epidemiology at the Neurological Institute of Columbia University College of Physicians and Surgeons, New York, USA and a member of the PRoFESS Steering Committee. "Patients with ischemic stroke have a high risk of recurrent stroke and death. While acetylsalicylic acid is proven and accepted as standard therapy in these patients, recent trials demonstrate that a combination of ASA and dipyridamole is superior to ASA. With PRoFESS we hope to gain further insight into the benefits of Aggrenox(R) in preventing a recurrent stroke, as well as the first direct comparison between the efficacy of Aggrenox(R) and clopidogrel."

Results from ESPRIT (European/Australasian Stroke Prevention in reversible Ischaemia Trial), published in the Lancet earlier this year, demonstrate that the combination of extended release dipyridamole plus acetylsalicylic acid (ASA) is superior to ASA alone as an antithrombotic prevention treatment for stroke patients[2].

There was a statistically significant 20 percent relative risk reduction of primary outcome events[xx] in patients treated with dipyridamole plus ASA compared with patients treated with ASA alone. The study results were consistent with the outcome of the earlier European Stroke Prevention Study-2 trial (ESPS-2), which demonstrated that Aggrenox(R)/Asasantin(R)Retard is twice as effective for the prevention of secondary stroke as either ASA or dipyridamole alone[3].

The use of Aggrenox(R)/Asasantin(R)Retard as a first-line treatment for secondary stroke prevention is recommended in many international guidelines such as those issued by the European Stroke Initiative (EUSI), the National Institute of Health and Clinical Excellence (NICE), the American College of Chest Physicians (ACCP) as well as the recently issued joint guidelines of the American Heart and Stroke Association (AHA/ASA).

Treatments used to reduce the risk of recurrent stroke work by inhibiting platelet aggregation and thrombus formation. Aggrenox(R) may possess multiple mechanisms of actions and additional pharmacological properties that may confer protective antithrombotic activity at the vessel wall with additional benefits for reducing the risk of recurrent stroke[3],[4],[5].

About PRoFESS

The PRoFESS study is a multi-center, randomized, double blind trial involving 720 sites from 35 countries. Patients 50 years or older who have had an ischemic stroke within the last 120 days and who were neurologically and clinically stable, were randomized to the study. The primary outcome for the trial is the time to any recurrent stroke. Secondary outcomes include, among others, the composite of stroke, myocardial infarction or vascular death with or without congestive heart failure, new onset diabetes, other designated vascular events. The comparison between ASA plus dipyridamole and clopidogrel is one to evaluate non-inferiority followed by superiority. Blocking the renin angiotensin system with ACE inhibitors or ARBs indicates that they reduce stroke. PRoFESS will determine if telmisartan shows superiority over placebo in reducing the risk of further strokes. PRoFESS is a study sponsored by Boehringer Ingelheim. For further information on PRoFESS, please visit http://www.profess.com.

About Aggrenox(R)

Aggrenox(R) is an antithrombotic that combines extended release dipyridamole and ASA. A product of Boehringer Ingelheim's research and development, it is indicated for the prevention of recurrent stroke and TIA. Marketed as Aggrenox(R) and as Asasantin(R) Retard it is available in more than 30 countries.

About Stroke

Stroke is an acute event, which arises from disease of the blood vessels that supply blood to the brain. A stroke or cerebrovascular accident (CVA) causes sudden damage to the brain tissue and occurs when a blood vessel that is carrying oxygen and other nutrients to the brain bursts or is clogged by a blood clot or particulate material.[6] The nerve cells are deprived of oxygen and die within minutes. Consequently, bodily functions under the control of those nerve cells will fail. The effects of a stroke are often permanent because the dead brain cells cannot be replaced.

About Transient Ischemic Attack (TIA)

TIA is often called a 'mini stroke' with symptoms very similar to a full stroke including sudden weakness, numbness, clumsiness or pins and needles on one side of the body; sudden loss of, or blurred sight in one or both eyes; and slurred speech or difficulty finding words. Without treatment a quarter of people suffering a TIA will go on to have a full-blown stroke within a few years.[7]

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit http://www.boehringer-ingelheim.com

Disclaimer: Press release for international use. As to the registration status in individual countries, please check with the contact address indicated below or liaise with the country-specific Boehringer Ingelheim affiliate.

References

[x] Acetylsalicylic acid (ASA) is also marketed as Aspirin(R)

[xx] Nonfatal stroke, death from all vascular causes, nonfatal myocardial infarction, or major bleeding complication. The dose range of ASA in ESPRIT was between 30 and 325mg/day, on average < 75mg/day. 83% of the patients received ER DIP, 8% the fixed dose combination ER DIP + ASA 200/25mg twice daily.

[1] Diener HC. Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS), Baseline Results. Presented on 26 Oct 2006 at Joint World Congress on Stroke

[2] Algra A et al. ESPRIT Study Group. Lancet 2006;367(9523):1665-73

[3] Diener HC, Cuhna L, Forbes C, Sivenius J, Smets P, Lowenthal A. European Stroke Prevention Study 2 (ESPS-2). Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci. 1996 Nov;143(1-2):1-13

[4] Weyrich AS et al. Dipyridamole selectively inhibits inflammatory gene expression in platelet-monocyte aggregates. Circulation 2005;111(5), 633-642

[5] Eisert WG. Dipyridamole. In Michelson A, editor. Platelets. London: Academic Press; 2002. P803-815

[6] Heart and Stroke Facts. The American Stroke Association

[7] Transient Ischaemic Attack Backgrounder. The Stroke Association UK

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