A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)
NCT ID: NCT00168792
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
1671 participants
INTERVENTIONAL
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Tenecteplase
PCI
Eligibility Criteria
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Inclusion Criteria
* Patients with a large acute myocardial infarction randomised within 6 hours of symptom onset
* Patients scheduled to undergo primary PCI
* Patients reaching the cath lab not before 60 min and not later than 3 hours after randomisation
(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI)
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Macan, Georgia, United States
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Detroit, Michigan, United States
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Omaha, Nebraska, United States
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Providence, Rhode Island, United States
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Feldkirch, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Wiener Neustadt, , Austria
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Aalst, , Belgium
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Anderlecht, , Belgium
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Angleur, , Belgium
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Antwerp, , Belgium
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Bonheiden, , Belgium
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Bouge, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Gilly, , Belgium
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Huy, , Belgium
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La Louvière, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Roeselare, , Belgium
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Blumenau - SC, , Brazil
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Curitiba - PR, , Brazil
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Marília - SP, , Brazil
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Passo Fundo - RS, , Brazil
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Porto Alegre - RS, , Brazil
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São Paulo - SP, , Brazil
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Victoria, British Columbia, Canada
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Greater Sudbury, Ontario, Canada
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Saint-Foy, Ontario, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Pardubice, , Czechia
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Prague, , Czechia
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Prague 4-Krc, , Czechia
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Aulnay-sous-Bois, , France
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Brest, , France
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Caen, , France
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Châteauroux, , France
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Clermont-Ferrand, , France
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Colmar, , France
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Créteil, , France
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Lille, , France
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Lorient, , France
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Lyon, , France
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Marseille, , France
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Massy, , France
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Metz, , France
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Montfermeil, , France
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Montpellier, , France
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Nice, , France
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Nîmes, , France
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Paris, , France
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Perpignan, , France
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Pontoise, , France
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Saint-Etienne, , France
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Strasbourg, , France
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Bad Friedrichshall, , Germany
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Bad Kreuznach, , Germany
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Bassum, , Germany
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Bautzen, , Germany
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Berlin, , Germany
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Bingen, , Germany
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Bonn, , Germany
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Boppard, , Germany
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Böblingen, , Germany
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Bremen, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Fürstenfeldbruck, , Germany
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Gransee, , Germany
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Hamelin, , Germany
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Heidelberg, , Germany
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Jena, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Koblenz, , Germany
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Korbach, , Germany
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Leipzig, , Germany
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Lichtenberg, , Germany
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Ludwigsburg, , Germany
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Mannheim, , Germany
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Minden, , Germany
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Möckmühl, , Germany
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Mönchengladbach, , Germany
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München, , Germany
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Offenbach, , Germany
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Öhringen, , Germany
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Paderborn, , Germany
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Ravensburg, , Germany
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Rüdesheim am Rhein, , Germany
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Schwalmstadt, , Germany
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Sömmerda, , Germany
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Wiesbaden, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Ioannina, , Greece
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Nea Efkarpia/ Thessaloniki, , Greece
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Nikaea, Piraeus, , Greece
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Rio, Patra, , Greece
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Thessaloniki, , Greece
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Galway, , Ireland
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Alessandria, , Italy
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Bassano del Grappa, , Italy
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Caserta, , Italy
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Catania, , Italy
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Cremona, , Italy
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Florence, , Italy
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Genova, , Italy
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Lecce, , Italy
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Lecco, , Italy
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Loreto Mare (NA), , Italy
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Mantova, , Italy
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Massa, , Italy
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Messina, , Italy
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Mirano (VE), , Italy
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Monza, , Italy
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Novara, , Italy
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Padua, , Italy
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Palermo, , Italy
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Pesaro, , Italy
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Potenza, , Italy
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Ravenna, , Italy
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Rho (mi), , Italy
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Roma, , Italy
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Salerno, , Italy
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San Donato Milanese, , Italy
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Sassari, , Italy
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Torino, , Italy
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Udine, , Italy
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Varese, , Italy
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Zingonia (bg), , Italy
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Col. Doctores, , Mexico
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Col. Granada, , Mexico
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Col. Magdalena de Las Salinas, , Mexico
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Col. Sección XVI, Deleg., , Mexico
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Col. Valle Verde, , Mexico
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Mèxico, D.F., , Mexico
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Bergen, , Norway
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Oslo, , Norway
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Katowice, , Poland
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Katowice-Ochojec, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Opole, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Almada, , Portugal
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Amadora, , Portugal
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Carnaxide, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Countries
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References
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Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators. Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006 Feb 18;367(9510):569-78. doi: 10.1016/S0140-6736(06)68147-6.
Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: an angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) trial. J Am Coll Cardiol. 2011 May 10;57(19):1867-73. doi: 10.1016/j.jacc.2010.10.061.
Jarai R, Huber K, Bogaerts K, Sinnaeve PR, Ezekowitz J, Ross AM, Zeymer U, Armstrong PW, Van de Werf FJ; ASSENT-4 PCI investigators. Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone [corrected] concentrations in ST elevation myocardial infarction: an analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial. Crit Care Med. 2010 Sep;38(9):1793-801. doi: 10.1097/CCM.0b013e3181eaaf2a.
Other Identifiers
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1123.12
Identifier Type: -
Identifier Source: org_study_id