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OHSU Trial Compares Drugs To Prevent Multiple Strokes

Portland resident hopes participation allows him to paint without it being 'tricky'.

Despite partially losing sight in his left eye, Kevan Lee-Andersen thought he was recovering well after suffering a stroke four years ago.

"Then I had the stroke in 2005," the Portland resident says.

Lee-Andersen, 57, hopes to prevent a third, perhaps more catastrophic stroke through a clinical trial he's participating in at Oregon Health & Science University. The trial, OHSU's biggest ever for stroke prevention, is comparing two pharmaceutical treatments to foil another occurrence of the neurological event.

Helmi Lutsep, M.D., associate professor of neurology, OHSU School of Medicine, and member of Oregon Stroke Center, is leading the university's involvement in the national trial, called PRoFESS. The study is comparing antiplatelet medications Aggrenox, a mix of low-dose aspirin and dipyridamole, with Plavix, also known as clopidogrel.

"This has been a huge study for us, with many local patients involved both from the Portland Veterans Affairs Medical Center and OHSU," says Lutsep, adding that both institutions have enrolled more than 80 study subjects, the second-highest number of participants in the country.

PRoFESS - Prevention Regimen For Effectively avoiding Second Strokes - involves about 20,000 participants observed for up to four years at more than 700 study sites in 35 countries in North and South America, Asia, Australia, Europe and South Africa. It is sponsored by Boehringer Ingelheim Pharmaceuticals Inc. and is the largest secondary stroke prevention trial ever conducted.

"These are patients who've had a recent stroke or transient ischemic attack. They're not in the acute phase. But we've learned that once you've had a TIA, you shouldn't say, 'I got off easily and I don't have to worry.' In fact, it's a warning that you're very likely to have another stroke."

Lutsep notes that while the risk of later strokes drops as time passes, it can still exist even years after the first or second event. "So it becomes more critical for us to act quickly for these patients and also find more treatments."

Previous studies have shown that combinations of antiplatelet agents, such as dipyridamole and aspirin, are more effective in preventing secondary strokes than a single agent, including aspirin.

"Aspirin already works, but we think we can do more," Lutsep said. "Now we're taking two drugs already compared against aspirin and asking which of these are best in stroke prevention. One of the most important things we can do is treat risk factors, such as high blood pressure, and tell people to stop smoking. After that, blood-thinning drugs can have an impact."

Aggrenox, made by Boehringer Ingelheim, and Plavix, manufactured by Bristol-Myers Squibb and Sanofi-Aventis, work by keeping platelets in the blood from sticking together and forming clots, which allows blood to flow more freely and reduces risk of heart attack or stroke. Aggrenox contains 200 milligrams of extended-release dipyridamole and 25 mg of aspirin, while Plavix is made up of 75 mg of clopidogrel.

In addition to the head-to-head comparison of Aggrenox and Plavix, the study will compare Micardis (telmisartan), also made by Boehringer Ingelheim, to placebo to determine whether the hypertension medication has "additional stroke prevention properties" in addition to reducing blood pressure, Lutsep said.

The randomized, double-blind, placebo-controlled study is following men and women age 50 and older who have had an ischemic stroke within the past 120 days. The trial duration is expected to finish in February 2008, according to Boehringer Ingelheim.

Lutsep said she hopes the trial yields more information about the causes of secondary strokes, which could help guide future treatment, as well as whether the drugs reduce the chances of heart attack in study participants, who are at increased risk for such events. She also wants to know more about the hemorrhaging that can occur with the use of blood-thinning drugs.

While Lutsep doesn't know whether Lee-Andersen is receiving Aggrenox or Plavix in the trial, she said his chances of a third stroke already were reduced when he had surgery to repair the carotid stenosis, or narrowing of the artery, that was behind his previous strokes.

"He's had surgery, so that halves his risk," she said. "That brings it way down, but it's still not zero. But if you don't do surgery, you're pretty much guaranteed another event. And that can be devastating because you're talking about a major vessel."

Lee-Andersen is hopeful the trial helps him avoid a third stroke. In the meantime, he'll continue to pursue his passion of abstract painting despite the poor vision in his left eye caused by the first stroke, and his inability to use his right arm because of the second stroke.

"It's a bit tricky using the brushes with my left hand, but I manage to a certain degree," Lee-Andersen said. "At the moment, I'm just experimenting. In the end, I want to get to the stage I was before I had these problems."

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