ASSENT 3

ASSENT 3

Assessment of the Safety of a New Thrombolytic-3. A clinical trial comparing the efficacy and safety of tenecteplase plus enoxaparin or abciximab with tenecteplase plus weight-adjusted unfractionated heparin in patients with acute myocardial infarction (MI).
Conclusion Tenecteplase plus enoxaparin or abciximab reduced ischaemic complications of an acute MI; tenecteplase plus enoxaparin may be a reperfusion regimen warranting further study.
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Genentech (NYSE:DNA) has announced that results from the ASSENT 3 PLUS trial demonstrate pre-hospital administration of the single-bolus thrombolytic (clot-dissolving) agent TNKase(TM) (Tenecteplase) to patients suffering from acute myocardial infarction (AMI, or heart attack) to be technically feasible and faster than in-hospital treatment.
The 1,639-patient, international, multicenter, randomized, open-label ASSENT 3 PLUS clinical trial was a satellite study of the larger hospital-based ASSENT 3 trial.
Lars Wallentin, Uppsala University, Uppsala, Sweden, and principal investigator of the ASSENT 3 PLUS study.
Genentech (NYSE:DNA) today announced that results from the ASSENT 3 PLUS trial demonstrate pre-hospital administration of the single-bolus thrombolytic (clot-dissolving) agent TNKase(TM) (Tenecteplase) to patients suffering from acute myocardial infarction (AMI, or heart attack) to be technically feasible and faster than in-hospital treatment.
Heart attack patients who received a new therapy regimen consisting of the single-bolus thrombolytic agent Metalyse(R)/TNKase(TM) (tenecteplase) and the low-molecular-weight heparin Clexane(R)/Lovenox(R) (enoxaparin sodium) experienced the most significant clinical efficacy and safety benefits in the ASSENT 3 (ASsessment of the Safety and Efficacy of New Thrombolytic regimens) trial.
ASSENT 3 enrolled 6,095 heart attack patients at more than 500 sites worldwide.
ASSENT 3 had two primary composite endpoints, primary efficacy and primary efficacy plus safety.
The largest of the studies is ASSENT 3 (ASsessment of the Safety and Efficacy of New Thrombolytic Regimens), a multicenter trial that will enroll 6,000 heart attack patients at more than 700 U.
In ASSENT 3, patients presenting within six hours of symptom onset will be randomized into three parallel treatment groups receiving varying doses of TNKase with heparin sodium (Group A), with enoxaparin sodium (Group B), or with the anti-platelet agent ReoPro(TM) (abciximab), manufactured by Centocor Pharmaceuticals, and heparin sodium (Group C).
An additional 1,000 patients will be randomized into a satellite study, ASSENT 3 Plus, investigating pre-hospital administration of either TNKase with enoxaparin sodium or TNKase with heparin sodium.
Heart attack patients who received a new therapy regimen consisting of the single-bolus thrombolytic agent TNKase(TM)/Metalyse(R) (tenecteplase) and the low-molecular-weight heparin Lovenox(R) (enoxaparin sodium) Injection experienced the most significant clinical efficacy and safety benefits in the ASSENT 3 (ASsessment of the Safety and Efficacy of New Thrombolytic regimens) trial.
ASSENT 3 had two primary composite endpoints: primary efficacy and primary efficacy plus safety.