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American Heart Association Late-Breaking Clinical Trial Report: New Blood Thinner for Angioplasty Patients Not Superior for Primary Endpoint, but Did Reduce Death and Stent Thrombosis
Date:11/15/2009

Study highlights:

- Used during coronary angioplasty plus stenting, in patients who all received clopidogrel after the procedure, a new reversible blood thinner did not have a significantly different effect from placebo on the composite endpoint of all-cause mortality, heart attack and need for new procedures to reopen coronary arteries.

- However, the investigational drug significantly lessened the risk for two pre-specified single secondary endpoints: all-cause mortality and in-stent blood clots.

ORLANDO, Fla., Nov. 15 /PRNewswire-USNewswire/ -- A new reversible blood thinner for angioplasty patients wasn't superior over placebo for its primary combined endpoint of heart attack, all-cause mortality and need for revascularization, but it reduced mortality and in-stent blood clots, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

CHAMPION PLATFORM, a phase III trial, included 5,362 angioplasty-plus-stent patients randomized to receive either a placebo or the investigational drug cangrelor during procedures to reopen coronary artery blockages. Cangrelor is a potent, fast-acting and reversible anti-clotting drug delivered intravenously.

After their procedures, all patients received 600 milligrams (mg) of the oral, nonreversible anti-clotting drug clopidogrel, which is routinely used in such procedures.

The trial, which enrolled patients beginning in 2006, ended when an interim review committee concluded that cangrelor would fail to show superiority over clopidogrel for its primary endpoint: a composite of all-cause death, heart attack and the need for coronary revascularization procedures.

"There was no statistically significant difference between the two arms of the trial at our 48-hour endpoint," said Deepak L. Bhatt, M.D., M.P.H., chief of cardiology at the VA Boston Healthcare System.
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SOURCE American Heart Association
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