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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1671 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tenecteplase

Intervention Type DRUG

PCI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients giving informed consent
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

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

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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)

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Countries

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Spain Taiwan United States Austria Belgium Brazil Canada Czechia France Germany Greece Hungary Ireland Italy Mexico Norway Poland Portugal Thailand Turkey (Türkiye)

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.

Reference Type RESULT
PMID: 16488800 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21545942 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20562693 (View on PubMed)

Other Identifiers

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1123.12

Identifier Type: -

Identifier Source: org_study_id