ITA
ENG

A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND MULTICENTER TRIAL OF A SINGLEBOLUS INJECTION OF THE NOVEL MODIFIED T-PA E6010 IN THE TREATMENT OF ACUTE MYOCARDIAL-INFARCTION - COMPARISON WITH NATIVE T-PA

Authors

KAWAI C YUI Y HOSODA S NOBUYOSHI M SUZUKI S SATO H TAKATSU F MOTOMIYA T KANMATSUSE K KODAMA K YABE Y MINAMINO T KIMATA SI NAKASHIMA M SUGIYAMA M SONE T HIASA Y KIJIMA M NAKAMURA N HAYASAKI K ABE H KADOWAKI K MURAYAMA H JOH T KATAGIRI T WATANABE S DOHI K TATEDA K MURATA M HAYASHIDA N ARITA M SAKAI K KITA T TODA H MEGURO T HARADA M HIGUMA N NAGAI T TAKIZAWA A HIRAYAMA H MURAKAMI E HIROSE K ISHISE S SHIMOMURA K INADA M CHINO M HIRAMORI K YOKOYAMA K MUNAKATA T TAKASE S SAITO S DOHI Y NAKAMURA H NISHIMURA H TAKAHASHI T KANAYA H TAKAHASHI M YOKOYAMA M IWASAKI T MITSUTO K HAYASHI Y OKUHARA T MATSUZAKI M YOROZU T TOSHIMA H ISHIKAWA K OGAWA H SYOUGASE T MIYAZAWA Y TAKEDA H SIBATA A YAMAGUCHI H TAKAHASHI S SAITO M NOMURA M TSUNEKAWA J NISHIKAWA H WAKABAYASHI A YOSHIKAWA J SHOJI K SAWAYAMA T HYAKUNA E TAKEDA H KIKUCHI Y DOI T YANO S TANAKA H KIMATA S

Citation

C. Kawai et al., A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND MULTICENTER TRIAL OF A SINGLEBOLUS INJECTION OF THE NOVEL MODIFIED T-PA E6010 IN THE TREATMENT OF ACUTE MYOCARDIAL-INFARCTION - COMPARISON WITH NATIVE T-PA, Journal of the American College of Cardiology, 29(7), 1997, pp. 1447-1453

Citations number

Categorie Soggetti

Cardiac & Cardiovascular System

Journal title

Journal of the American College of Cardiology → ACNP

ISSN journal

07351097

Volume

Issue

Year of publication

1997

Pages

1447 - 1453

Database

ISI

SICI code

0735-1097(1997)29:7<1447:APRDMT>2.0.ZU;2-#

Abstract

Objectives. This prospective, randomized, double-blind multicenter tri al evaluated the efficacy and safety of a single bolus injection of th e novel modified tissue-type plasminogen activator (t-PA) E6010 in the treatment of acute myocardial infarction compared with that of native t-PA. Background. E6010 is a novel modified t-PA with a prolonged hal f-life (t(1/2) alpha greater than or equal to 23 min) compared with na tive t-PA (t(1/2) alpha = 4 min). E6010 can be administered in patient s as a single intravenous bolus injection, and early recanalization ca n be expected. Methods. The efficacy of E6010 was compared with that o f native t-PA in 199 patients,vith acute myocardial infarction who wer e treated within 6 h of onset in a prospective, randomized, double-bli nd multicenter trial. Patients were given either 0.22 mg/kg body weigh t of E6010 intravenously over 2 min or native t-PA (tisokinase) 28.8 m g or 14.4 million IU (10% of the total dose over 1 to 2 min, the remai nder infused over 60 min). Results. The primary end point was the reca nalization rate of the infarct-related coronary artery at 60 min after the start of treatment. Time to reperfusion was shorter in the E6010 group than in the native t-PA group. Thrombolysis in Myocardial Infarc tion how grade 2 or 3 recanalization at 15, 30, 45 and 60 min after ad ministration was observed in 37%, 62%, 74% and 79% (95% confidence int erval [CI] 70% to 87%) of the E6010-treated patients and in 14%, 32%, 50% and 65% (95% CI 55% to 74%) of native t-PA-treated patients, respe ctively (p = 0.032 at 60 min). Conclusions. The present study indicate s that, compared with native t-PA, a single bolus injection of E6010 o ver 2 min produces a higher rate of early recanalization of the infarc t-related coronary artery without fatal bleeding complications. (C) 19 97 by the American College of Cardiology.