Drug from Magnolia
A new drug derived from Magnolia tree appears to help better control the potentially dangerous complications of bleeding and clot formation during procedures to open blocked coronary arteries.
Results of the Phase II study of the drug, provisionally known as SCH 530348, by researchers at the Duke Clinical Research Institute in the US, appear in the March issue of The Lancet. An international Phase III study is now under way.
The drug helps uncouple two important functions of thrombin, a protein in the blood that performs two key functions in clot formation: it activates platelets, particles that clump together to form the scaffolding of a clot, and it helps produce fibrin, a protein necessary in repairing damaged tissue.
“One of the intriguing things about this new investigational compound is that it blocks the thrombin receptor that activates platelet formation yet preserves the beneficial activity of fibrin formation,” says Richard Becker, a cardiologist at DCRI and lead author of the study.
“And the data to date indicated the compound does this even when patients are taking aspirin and clopidogrel.”
Blood clots are a big issue for patients facing percutaneous coronary intervention (PCI), the process of clearing clogged arteries with a balloon and then propping them open with stents. Patients who undergo PCI are usually prescribed anti-clotting agents, such as aspirin or clopidgrel.
Becker says while those drugs are effective, they can sometimes lead to bleeding, and with current therapy, the rate of additional cardiovascular events remains quite high.
“So there is a very aggressive search going on for better and safer agents,” he says.
In the current study, researchers randomly assigned 1030 patients 45 years or older, scheduled to undergo non-urgent PCI or angiography with planned PCI, to a group that would receive one of three escalating doses of SCH 530348 (10mg, 20mg or 40mg), or to a control group, which took a placebo. Researchers and patients were both blinded to who was taking which drug.
They found SCH 530348 was generally tolerable at all dosing levels and did not increase bleeding, even when taken along with aspirin and clopidogrel.
