Clinical trial NCT00168792: 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)
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. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2005-09-15
Enrollment: 1671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Exclusion Criteria: None

Primary outcomes:
measure: Death or cardiogenic shock or congestive heart failure within 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Death or cardiogenic shock or congestive heart failure within 30 days
timeFrame: 30 days
measure: Cardiogenic shock or congestive heart failure within 90 days
timeFrame: 90 days
measure: Death
timeFrame: 90 days
measure: Cardiogenic shock
timeFrame: 90 days
measure: Reinfarction
timeFrame: 90 days
measure: Repeat target vessel revascularisation (TVR)
timeFrame: 90 days
measure: Rehospitalisation for congestive heart failure
timeFrame: 90 days
measure: Rehospitalisation for cardiogenic shock
timeFrame: 90 days
measure: Rehospitalisation for other cardiac reasons
timeFrame: 90 days
measure: Congestive heart failure
timeFrame: 90 days
measure: N-terminal pro-brain natriuretic peptide (NT pro-BNP)
timeFrame: 90 days
measure: Disabling stroke
timeFrame: 90 days
measure: Total stroke
timeFrame: 90 days
measure: Rehospitalisation for stroke or ICH (intrancranial haemorrhage)
timeFrame: 90 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arkansas
city: Fort Lauderdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Macan
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Georgia
city: Detroit
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nebraska
city: Providence
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Feldkirch
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Pölten
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wr. Neustadt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Aalst
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Antwerpen
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Bonheiden
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Brugge
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Bruxelles / Anderlecht
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Charleroi
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Genk
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Gilly
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Huy
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: La Louvière
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Liège-Angleur
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Namur/Bouge
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Namur
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Roeselare
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Blumenau - SC
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Curitiba - PR
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Marília - SP
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Passo Fundo - RS
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Porto Alegre - RS
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: São Paulo - SP
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Victoria
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: British Columbia
city: Saint-Foy
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Pardubice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Prague 4-Krc
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Prague 5
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Aulnay sous Bois
country: France
facility: Boehringer Ingelheim Investigational Site
city: Brest
country: France
facility: Boehringer Ingelheim Investigational Site
city: Caen
country: France
facility: Boehringer Ingelheim Investigational Site
city: Châteauroux
country: France
facility: Boehringer Ingelheim Investigational Site
city: Clermont-Ferrand
country: France
facility: Boehringer Ingelheim Investigational Site
city: Colmar
country: France
facility: Boehringer Ingelheim Investigational Site
city: Créteil
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lorient
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Massy
country: France
facility: Boehringer Ingelheim Investigational Site
city: Metz
country: France
facility: Boehringer Ingelheim Investigational Site
city: Montfermeil
country: France
facility: Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nice
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nîmes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: Boehringer Ingelheim Investigational Site
city: Pontoise
country: France
facility: Boehringer Ingelheim Investigational Site
city: Saint Etienne
country: France
facility: Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: Boehringer Ingelheim Investigational Site
city: Bad Friedrichshall
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Kreuznach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bassum
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bautzen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin-Lichtenberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Boppard
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Böblingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fürstenfeldbruck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gransee
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hameln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Jena
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kassel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Korbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ludwigsburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Minden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Möckmühl
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mönchengladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Offenbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Paderborn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ravensburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rüdesheim am Rhein
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwalmstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sömmerda
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Öhringen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Heraklion
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Ioannina
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Nea Efkarpia/ Thessaloniki
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Nikaea, Piraeus
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Rio, Patra
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: Boehringer Ingelheim Investigational Site
city: Balatonfüred
country: Hungary
facility: Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: Boehringer Ingelheim Investigational Site
city: Pécs
country: Hungary
facility: Boehringer Ingelheim Investigational Site
city: Galway
country: Ireland
facility: Boehringer Ingelheim Investigational Site
city: Alessandria
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Bassano del Grappa
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Caserta
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Cremona
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Lecce
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Lecco
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Loreto Mare (NA)
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Mantova
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Massa
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Messina
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Mirano (VE)
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Monza
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Novara
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Padova
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Pesaro
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Potenza
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Ravenna
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Rho (mi)
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Salerno
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: San Donato Milanese
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Sassari
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Udine
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Varese
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Zingonia (bg)
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: col. Doctores
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Col. Granada
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Col. Magdalena de las Salinas
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Col. Sección XVI, Deleg.
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Col. Valle Verde
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Mèxico, D.F.
country: Mexico
facility: Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: Boehringer Ingelheim Investigational Site
city: Katowice-Ochojec
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Katowice
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Lublin
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Opole
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Zabrze
country: Poland
facility: Boehringer Ingelheim Investigational Site
city: Almada
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Carnaxide
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: Boehringer Ingelheim Investigational Site
city: Chiangmai
country: Thailand
facility: Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.