A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)

Condition(s) targeted: Myocardial Infarction

Intervention: Tenecteplase (Drug); PCI (Procedure)

Phase: Phase 4

Status: Terminated

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.

Official title: A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: As the main criteria for measuring clinical outcome, the frequency of death, heart failure or cardiogenic shock is compared in the two treatment groups during 90 days after the acute heart attack.

Secondary outcome:

As a secondary outcome any other in-hospital complication and bleeds (including intracranial bleeds) are recorded and the frequency compared in the two treatment groups.

Furthermore, intracoronary blood flow measured during catheterisation before and after the PCI and a laboratory blood test (BNP) predicting developing heart failure are compared between the groups.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Patients giving informed consent and with a large acute myocardial infarction randomised within 6 hours of symptom onset, scheduled to undergo primary PCI and reaching the cath lab not before 60 min and not later than 3 hours after randomisation. Otherwise the patients fulfil the usual selection criteria for thrombolytic treatment and PCI.

Boehringer Ingelheim Investigational Site, Feldkirch, Austria

Boehringer Ingelheim Investigational Site, St. Pölten, Austria

Boehringer Ingelheim Investigational Site, Wien, Austria

Boehringer Ingelheim Investigational Site, Wr. Neustadt, Austria

Boehringer Ingelheim Investigational Site, Aalst, Belgium

Boehringer Ingelheim Investigational Site, Antwerpen, Belgium

Boehringer Ingelheim Investigational Site, Bonheiden, Belgium

Boehringer Ingelheim Investigational Site, Brugge, Belgium

Boehringer Ingelheim Investigational Site, Brussel, Belgium

Boehringer Ingelheim Investigational Site, Bruxelles, Belgium

Boehringer Ingelheim Investigational Site, Bruxelles / Anderlecht, Belgium

Boehringer Ingelheim Investigational Site, Charleroi, Belgium

Boehringer Ingelheim Investigational Site, Genk, Belgium

Boehringer Ingelheim Investigational Site, Gent, Belgium

Boehringer Ingelheim Investigational Site, Gilly, Belgium

Boehringer Ingelheim Investigational Site, Huy, Belgium

Boehringer Ingelheim Investigational Site, La Louvière, Belgium

Boehringer Ingelheim Investigational Site, Leuven, Belgium

Boehringer Ingelheim Investigational Site, Liège, Belgium

Boehringer Ingelheim Investigational Site, Liège-Angleur, Belgium

Boehringer Ingelheim Investigational Site, Namur, Belgium

Boehringer Ingelheim Investigational Site, Namur/Bouge, Belgium

Boehringer Ingelheim Investigational Site, Roeselare, Belgium

Boehringer Ingelheim Investigational Site, Blumenau - SC, Brazil

Boehringer Ingelheim Investigational Site, Curitiba - PR, Brazil

Boehringer Ingelheim Investigational Site, Marília - SP, Brazil

Boehringer Ingelheim Investigational Site, Passo Fundo - RS, Brazil

Boehringer Ingelheim Investigational Site, Porto Alegre - RS, Brazil

Boehringer Ingelheim Investigational Site, São Paulo - SP, Brazil

Boehringer Ingelheim Investigational Site, Pardubice, Czech Republic

Boehringer Ingelheim Investigational Site, Prague 4-Krc, Czech Republic

Boehringer Ingelheim Investigational Site, Prague 5, Czech Republic

Boehringer Ingelheim Investigational Site, Aulnay sous Bois, France

Boehringer Ingelheim Investigational Site, Brest, France

Boehringer Ingelheim Investigational Site, Caen, France

Boehringer Ingelheim Investigational Site, Châteauroux, France

Boehringer Ingelheim Investigational Site, Clermont-Ferrand, France

Boehringer Ingelheim Investigational Site, Colmar, France

Boehringer Ingelheim Investigational Site, Créteil, France

Boehringer Ingelheim Investigational Site, Lille, France

Boehringer Ingelheim Investigational Site, Lorient, France

Boehringer Ingelheim Investigational Site, Lyon, France

Boehringer Ingelheim Investigational Site, Marseille, France

Boehringer Ingelheim Investigational Site, Massy, France

Boehringer Ingelheim Investigational Site, Metz, France

Boehringer Ingelheim Investigational Site, Montfermeil, France

Boehringer Ingelheim Investigational Site, Montpellier, France

Boehringer Ingelheim Investigational Site, Nice, France

Boehringer Ingelheim Investigational Site, Nîmes, France

Boehringer Ingelheim Investigational Site, Paris, France

Boehringer Ingelheim Investigational Site, Perpignan, France

Boehringer Ingelheim Investigational Site, Pontoise, France

Boehringer Ingelheim Investigational Site, Saint Etienne, France

Boehringer Ingelheim Investigational Site, Strasbourg, France

Boehringer Ingelheim Investigational Site, Bad Friedrichshall, Germany

Boehringer Ingelheim Investigational Site, Bad Kreuznach, Germany

Boehringer Ingelheim Investigational Site, Bassum, Germany

Boehringer Ingelheim Investigational Site, Bautzen, Germany

Boehringer Ingelheim Investigational Site, Berlin, Germany

Boehringer Ingelheim Investigational Site, Berlin-Lichtenberg, Germany

Boehringer Ingelheim Investigational Site, Bingen, Germany

Boehringer Ingelheim Investigational Site, Bonn, Germany

Boehringer Ingelheim Investigational Site, Boppard, Germany

Boehringer Ingelheim Investigational Site, Bremen, Germany

Boehringer Ingelheim Investigational Site, Böblingen, Germany

Boehringer Ingelheim Investigational Site, Dresden, Germany

Boehringer Ingelheim Investigational Site, Fürstenfeldbruck, Germany

Boehringer Ingelheim Investigational Site, Gransee, Germany

Boehringer Ingelheim Investigational Site, Hameln, Germany

Boehringer Ingelheim Investigational Site, Heidelberg, Germany

Boehringer Ingelheim Investigational Site, Jena, Germany

Boehringer Ingelheim Investigational Site, Kassel, Germany

Boehringer Ingelheim Investigational Site, Kiel, Germany

Boehringer Ingelheim Investigational Site, Koblenz, Germany

Boehringer Ingelheim Investigational Site, Korbach, Germany

Boehringer Ingelheim Investigational Site, Köln, Germany

Boehringer Ingelheim Investigational Site, Leipzig, Germany

Boehringer Ingelheim Investigational Site, Ludwigsburg, Germany

Boehringer Ingelheim Investigational Site, Mannheim, Germany

Boehringer Ingelheim Investigational Site, Minden, Germany

Boehringer Ingelheim Investigational Site, Möckmühl, Germany

Boehringer Ingelheim Investigational Site, Mönchengladbach, Germany

Boehringer Ingelheim Investigational Site, München, Germany

Boehringer Ingelheim Investigational Site, Offenbach, Germany

Boehringer Ingelheim Investigational Site, Paderborn, Germany

Boehringer Ingelheim Investigational Site, Ravensburg, Germany

Boehringer Ingelheim Investigational Site, Rüdesheim am Rhein, Germany

Boehringer Ingelheim Investigational Site, Schwalmstadt, Germany

Boehringer Ingelheim Investigational Site, Sömmerda, Germany

Boehringer Ingelheim Investigational Site, Wiesbaden, Germany

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Boehringer Ingelheim Investigational Site, Athens, Greece

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Boehringer Ingelheim Investigational Site, Ioannina, Greece

Boehringer Ingelheim Investigational Site, Nea Efkarpia/ Thessaloniki, Greece

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Boehringer Ingelheim Investigational Site, Rio, Patra, Greece

Boehringer Ingelheim Investigational Site, Thessaloniki, Greece

Boehringer Ingelheim Investigational Site, Balatonfüred, Hungary

Boehringer Ingelheim Investigational Site, Budapest, Hungary

Boehringer Ingelheim Investigational Site, Debrecen, Hungary

Boehringer Ingelheim Investigational Site, Pécs, Hungary

Boehringer Ingelheim Investigational Site, Galway, Ireland

Boehringer Ingelheim Investigational Site, ALESSANDRIA, Italy

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Boehringer Ingelheim Investigational Site, Loreto Mare (NA), Italy

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Boehringer Ingelheim Investigational Site, SAN DONATO MILANESE, Italy

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Boehringer Ingelheim Investigational Site, VARESE, Italy

Boehringer Ingelheim Investigational Site, ZINGONIA (BG), Italy

Boehringer Ingelheim Investigational Site, Col. Granada, Mexico

Boehringer Ingelheim Investigational Site, Col. Magdalena de las Salinas, Mexico

Boehringer Ingelheim Investigational Site, Col. Sección XVI, Deleg., Mexico

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Boehringer Ingelheim Investigational Site, Mèxico, D.F., Mexico

Boehringer Ingelheim Investigational Site, col. Doctores, Mexico

Boehringer Ingelheim Investigational Site, BERGEN, Norway

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Boehringer Ingelheim Investigational Site, Katowice, Poland

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Boehringer Ingelheim Investigational Site, Krakow, Poland

Boehringer Ingelheim Investigational Site, Lodz, Poland

Boehringer Ingelheim Investigational Site, Lublin, Poland

Boehringer Ingelheim Investigational Site, Opole, Poland

Boehringer Ingelheim Investigational Site, Poznan, Poland

Boehringer Ingelheim Investigational Site, Warsaw, Poland

Boehringer Ingelheim Investigational Site, Wroclaw, Poland

Boehringer Ingelheim Investigational Site, Zabrze, Poland

Boehringer Ingelheim Investigational Site, Almada, Portugal

Boehringer Ingelheim Investigational Site, Amadora, Portugal

Boehringer Ingelheim Investigational Site, Carnaxide, Portugal

Boehringer Ingelheim Investigational Site, Coimbra, Portugal

Boehringer Ingelheim Investigational Site, Lisboa, Portugal

Boehringer Ingelheim Investigational Site, Porto, Portugal

Boehringer Ingelheim Investigational Site, Vila Nova de Gaia, Portugal

Boehringer Ingelheim Investigational Site, Bangkok, Thailand

Boehringer Ingelheim Investigational Site, Chiangmai, Thailand

Boehringer Ingelheim Investigational Site, Ankara, Turkey

Boehringer Ingelheim Investigational Site, Istanbul, Turkey

Boehringer Ingelheim Investigational Site, Izmir, Turkey

Boehringer Ingelheim Investigational Site, Little Rock, Arkansas, United States

Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada

Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States

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Boehringer Ingelheim Investigational Site, Tampa, Florida, United States

Boehringer Ingelheim Investigational Site, Macan, Georgia, United States

Boehringer Ingelheim Investigational Site, Detroit, Michigan, United States

Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States

Boehringer Ingelheim Investigational Site, Saint-Foy, Ontario, Canada

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Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States

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Starting date: November 2003
Ending date: October 2006
Last updated: August 3, 2006