While taking the blood thinner Plavix with aspirin may decrease the risk of a recurring stroke, researchers warn that the combo also significantly increases the risk of major bleeding events.
In a study published July 19 in the New England Journal of Medicine, researchers with the University of Texas indicate that when compared to use of just aspirin alone, major hemorrhaging was more than twice as likely to occur among patients taking as well Plavix (clopidogrel), a combination known as dual antiplatelet therapy (DAPT).
The bleeding risks were high enough, and the results conclusive enough, that the study was halted before completion for the safety of patients. When the study was stopped, 84% of the number of anticipated patients had been enrolled. Researchers said the data and safety monitoring board determined at that time that there was a high risk of hemorrhage among the patients given DAPT, and that there was enough evidence to show that there was reduced risk of stroke among those patients as well.
The study involved a randomized trial with 4,881 patients at 269 international sites. Researchers looked for patients who had suffered either a minor ischemic stroke or a transient ischemic attack (TIA) and prescribed them either Plavix plus aspirin, or aspirin alone.
According to the findings, the combination of the two medications decreased the risk of stroke by 25%. However, the risk of major hemorrhage was doubled, with 23 patients suffering major bleeding events among the Plavix and aspirin group, compared to just 10 patients who suffered similar events in the group given just aspirin.
“In patients with minor ischemic stroke or high-risk TIA, those who received a combination of clopidogrel and aspirin had a lower risk of major ischemic events but a higher risk of major hemorrhage at 90 days than those who received aspirin alone,” the researchers concluded.
A study earlier this year found that the combination of the two drugs could also increase the risk of heart attacks. In March, South Korean researchers published a study in the medical journal The Lancet, which found little benefit in giving the two drugs to patients who had recently been implanted with a coronary stent.
Patients given the two drugs for six months faced an increased risk of heart attacks and were more likely to suffer stent thrombosis.