ARTICLE | Clinical News
Hirudin anticoagulant data
September 19, 1994 7:00 AM UTC
Ciba reported data from its Phase III HELVETICA trial of Hirudin in patients with unstable angina at the Berlin meeting of the World Congress of Cardiology. In April, Ciba had put its Phase III trials in angioplasty and myocardial infarction on hold due to bleeding issues, specifically a high intracranial bleed (stroke) rate. The trials resumed in May after dosages were reduced.
There were no statistically significant differences in the primary end point, a composite at 7 months of death, myocardial infarction, coronary artery bypass graft surgery or stent, and repeat angioplasty. The occurrence of adverse events was 32.7 percent in the heparin group, 36.6 percent in the Hirudin iv group, and 32.0 percent in the Hirudin iv+sc group. ...