ADVANCE MI

ADVANCE MI

ADdressing the Value of Facilitated ANgioplasty after Combination Therapy or Eptifibatide Monotherapy in Acute Myocardial Infarction. A clinical trial designed to evaluate the effect of combining emergent angioplasty < 6 hours post chest pain with half-dose thrombolytics in acute myocardial infarction; patients received a 50% standard dose of tenecteplase and eptifibatide—a gp IIb/IIIa inhibitor; in each treatment, patients received either open-label unfractionated heparin or open-label enoxaparin.
Conclusion The combined primary endpoint of death or severe congestive heart failure was 11% in eptifibatide + tenecteplase patients and 1% with eptifibatide-only patients (p = 0.02). Bleeding complications were significantly higher in eptifibatide + tenecteplase patients than in eptifibatide-only patients. The goal was to enroll 5,640 patients, but it was ended at 148 patients as the trial would not have been completed in a reasonable time frame.
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The trial, known as ADVANCE MI (ADdressing the Value of Facilitated ANgioplasty after Combination Therapy or Eptifibatide Monotherapy in Acute Myocardial Infarction), will evaluate the safety and efficacy of INTEGRILIN alone or in combination with reduced-dosed tenecteplase, a fibrinolytic, or "clot- busting," treatment followed by percutaneous coronary angioplasty within four hours in heart attack patients.
The initiation of ADVANCE MI represents an important step in the clinical development of INTEGRILIN and in the growth of our cardiovascular franchise," said Arthur Hiller, general manager of the Millennium cardiovascular franchise.
ADVANCE MI is assessing the use of INTEGRILIN alone or in combination with reduced-dose tenecteplase administered upon diagnosis of a heart attack to restore blood flow to the heart muscle.
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