Every year, about 800,000 to 1 million American patients have one or more stents implanted inside their bodies to keep the artery open after it has been cleared out by angioplasty. While there is less than 1 percent has a clot form near the stent, there are still many complications, ranging from clots to strokes, heart attacks and even deaths.
In order to find out the best way to prevent potentially deadly blood clots from forming in heart patients who have artery-opening stents implanted, several competing drug and medical device makers are joining hands to start a new study, which also involves academic researchers and federal regulators, to find out how long patients should take blood-thinning medicine.
Since early this year, the trial has already been planned but the initial details were announced only on October 15, 2008 at a medical conference. The study will involve and be partly supported by the 4 United States competitors in the stent market plus 4 drug makers.
The multi-center study, which is expected to begin enrolling patients later 2008 or early 2009, will involve about 25,000 to 30,000 patients who have had one of the tiny, metal-mesh tubes implanted in a heart artery.
Most of these patients have today’s widely used drug-coated stents that will over time release a medication meant to prevent the artery from re-clogging. On the other hand, at least 5,000 of the participants will get older, bare-metal stents.
According to the investigators, patients in the study will get now-standard preventive treatment for a year after getting a stent implanted. Such treatment involves an anti-clotting drug and at least 81 mg of aspirin a day.
At the end of the one-year study, those who have no complications will be randomized, with half of them continuing on the dual blood-thinning therapy for an additional 18 months and the rest stopping it. Researchers will then determine which group had more heart attacks, strokes and deaths, as well as clots inside the stents.
In order to find out the best way to prevent potentially deadly blood clots from forming in heart patients who have artery-opening stents implanted, several competing drug and medical device makers are joining hands to start a new study, which also involves academic researchers and federal regulators, to find out how long patients should take blood-thinning medicine.
Since early this year, the trial has already been planned but the initial details were announced only on October 15, 2008 at a medical conference. The study will involve and be partly supported by the 4 United States competitors in the stent market plus 4 drug makers.
The multi-center study, which is expected to begin enrolling patients later 2008 or early 2009, will involve about 25,000 to 30,000 patients who have had one of the tiny, metal-mesh tubes implanted in a heart artery.
Most of these patients have today’s widely used drug-coated stents that will over time release a medication meant to prevent the artery from re-clogging. On the other hand, at least 5,000 of the participants will get older, bare-metal stents.
According to the investigators, patients in the study will get now-standard preventive treatment for a year after getting a stent implanted. Such treatment involves an anti-clotting drug and at least 81 mg of aspirin a day.
At the end of the one-year study, those who have no complications will be randomized, with half of them continuing on the dual blood-thinning therapy for an additional 18 months and the rest stopping it. Researchers will then determine which group had more heart attacks, strokes and deaths, as well as clots inside the stents.
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