The Japanese study was funded by Pletal's maker, Otsuka Pharmaceutical, and tracked outcomes for people with the most common form of stroke, ischemic stroke. These are strokes caused by blocked blood flow to the brain.
Low-dose aspirin and clopidogrel have been shown to reduce the risk of a second stroke early in ischemic stroke patients' recovery, said study lead author Dr. Kazunori Toyoda. But he added that the benefits of those two blood thinners are brief and must be balanced with a risk of major bleeding after long-term use.
Toyoda is deputy director general of the National Cerebral and Cardiovascular Center in Suita, Osaka, Japan.
Pletal has been shown to prevent further strokes in stroke patients without increasing serious bleeding as compared to aspirin, Toyoda said. So his team decided to assess whether long-term use of the drug with other blood thinners might be safe and effective.
The study included more than 1,800 high-risk patients in Japan who had suffered an ischemic stroke up to six months earlier. Each was randomly assigned to receive aspirin or clopidogrel alone, or a combination of Pletal with aspirin or clopidogrel, at one of 292 sites across Japan over about three years.
As reported Feb. 6 at the American Stroke Association's annual meeting in Honolulu, Hawaii, the study found the risk of another ischemic stroke was halved for patients who took Pletal plus aspirin or clopidogrel, versus those who took aspirin or clopidogrel alone.
Specially, 29 of 913 patients (3.2 percent) who took Pletal plus another blood thinner went on to have another stroke, compared to 64 of 926 patients (6.9 percent) who took aspirin or clopidogrel alone, the investigators found.
Adding Pletal to the mix didn't seem to affect patient safety, however. According to the researchers, patients in the study experienced a similar risk of major bleeding -- about 1 percent -- regardless of which regimen they were on.
One cardiologist who wasn't connected to the new study said the findings were encouraging.
"The decrease in stroke recurrence with unchanged bleeding risk is remarkable," said Dr. Satjit Bhusri, who practices at Lenox Hill Hospital in New York City.
"Stroke treatment has long lagged heart attack treatment," Bhusri said. "It is reassuring to see that similar treatments correlate and if this continues, we can further study more advanced medicines already used in the heart for the brain as well."
Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal.
The National Stroke Association has more on ischemic stroke.
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