Myocardial Infarction Clinical Trial
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.)
| Verified date | October 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1671 |
| Est. completion date | |
| Est. primary completion date | July 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | 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 | |
| Belgium | 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 | |
| Brazil | 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 | |
| Canada | Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | Boehringer Ingelheim Investigational Site | Regina | Saskatchewan |
| Canada | Boehringer Ingelheim Investigational Site | Saint-Foy | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan |
| Canada | Boehringer Ingelheim Investigational Site | Sudbury | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Victoria | British Columbia |
| Czech Republic | Boehringer Ingelheim Investigational Site | Pardubice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Prague 4-Krc | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Prague 5 | |
| France | 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 | |
| Germany | 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 | Böblingen | |
| Germany | Boehringer Ingelheim Investigational Site | Bonn | |
| Germany | Boehringer Ingelheim Investigational Site | Boppard | |
| Germany | Boehringer Ingelheim Investigational Site | Bremen | |
| 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 | Köln | |
| Germany | Boehringer Ingelheim Investigational Site | Korbach | |
| 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 | Öhringen | |
| 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 | |
| Greece | Boehringer Ingelheim Investigational Site | Athens | |
| Greece | Boehringer Ingelheim Investigational Site | Heraklion | |
| Greece | Boehringer Ingelheim Investigational Site | Ioannina | |
| Greece | Boehringer Ingelheim Investigational Site | Nea Efkarpia/ Thessaloniki | |
| Greece | Boehringer Ingelheim Investigational Site | Nikaea, Piraeus | |
| Greece | Boehringer Ingelheim Investigational Site | Rio, Patra | |
| Greece | Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Hungary | Boehringer Ingelheim Investigational Site | Balatonfüred | |
| Hungary | Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | Boehringer Ingelheim Investigational Site | Debrecen | |
| Hungary | Boehringer Ingelheim Investigational Site | Pécs | |
| Ireland | Boehringer Ingelheim Investigational Site | Galway | |
| Italy | Boehringer Ingelheim Investigational Site | Alessandria | |
| Italy | Boehringer Ingelheim Investigational Site | Bassano del Grappa | |
| Italy | Boehringer Ingelheim Investigational Site | Caserta | |
| Italy | Boehringer Ingelheim Investigational Site | Catania | |
| Italy | Boehringer Ingelheim Investigational Site | Cremona | |
| Italy | Boehringer Ingelheim Investigational Site | Firenze | |
| Italy | Boehringer Ingelheim Investigational Site | Genova | |
| Italy | Boehringer Ingelheim Investigational Site | Lecce | |
| Italy | Boehringer Ingelheim Investigational Site | Lecco | |
| Italy | Boehringer Ingelheim Investigational Site | Loreto Mare (NA) | |
| Italy | Boehringer Ingelheim Investigational Site | Mantova | |
| Italy | Boehringer Ingelheim Investigational Site | Massa | |
| Italy | Boehringer Ingelheim Investigational Site | Messina | |
| Italy | Boehringer Ingelheim Investigational Site | Mirano (VE) | |
| Italy | Boehringer Ingelheim Investigational Site | Monza | |
| Italy | Boehringer Ingelheim Investigational Site | Novara | |
| Italy | Boehringer Ingelheim Investigational Site | Padova | |
| Italy | Boehringer Ingelheim Investigational Site | Palermo | |
| Italy | Boehringer Ingelheim Investigational Site | Pesaro | |
| Italy | Boehringer Ingelheim Investigational Site | Potenza | |
| Italy | Boehringer Ingelheim Investigational Site | Ravenna | |
| Italy | Boehringer Ingelheim Investigational Site | Rho (mi) | |
| Italy | Boehringer Ingelheim Investigational Site | Roma | |
| Italy | Boehringer Ingelheim Investigational Site | Salerno | |
| Italy | Boehringer Ingelheim Investigational Site | San Donato Milanese | |
| Italy | Boehringer Ingelheim Investigational Site | Sassari | |
| Italy | Boehringer Ingelheim Investigational Site | Torino | |
| Italy | Boehringer Ingelheim Investigational Site | Udine | |
| Italy | Boehringer Ingelheim Investigational Site | Varese | |
| Italy | Boehringer Ingelheim Investigational Site | Zingonia (bg) | |
| Mexico | Boehringer Ingelheim Investigational Site | col. Doctores | |
| Mexico | 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 | Boehringer Ingelheim Investigational Site | Col. Valle Verde | |
| Mexico | Boehringer Ingelheim Investigational Site | Mèxico, D.F. | |
| Norway | Boehringer Ingelheim Investigational Site | Bergen | |
| Norway | Boehringer Ingelheim Investigational Site | Oslo | |
| Poland | Boehringer Ingelheim Investigational Site | Katowice | |
| Poland | Boehringer Ingelheim Investigational Site | Katowice-Ochojec | |
| Poland | 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 | |
| Portugal | 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 | |
| Thailand | Boehringer Ingelheim Investigational Site | Bangkok | |
| Thailand | Boehringer Ingelheim Investigational Site | Chiangmai | |
| Turkey | Boehringer Ingelheim Investigational Site | Ankara | |
| Turkey | Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | Boehringer Ingelheim Investigational Site | Izmir | |
| United States | Boehringer Ingelheim Investigational Site | Detroit | Michigan |
| United States | Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| United States | Boehringer Ingelheim Investigational Site | Little Rock | Arkansas |
| United States | Boehringer Ingelheim Investigational Site | Macan | Georgia |
| United States | Boehringer Ingelheim Investigational Site | Omaha | Nebraska |
| United States | Boehringer Ingelheim Investigational Site | Providence | Rhode Island |
| United States | Boehringer Ingelheim Investigational Site | St. Petersburg | Florida |
| United States | Boehringer Ingelheim Investigational Site | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Genentech, Inc. |
United States, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Norway, Poland, Portugal, Thailand, Turkey,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Death or cardiogenic shock or congestive heart failure within 90 days | 90 days | No | |
| Secondary | Death or cardiogenic shock or congestive heart failure within 30 days | 30 days | No | |
| Secondary | Cardiogenic shock or congestive heart failure within 90 days | 90 days | No | |
| Secondary | Death | 90 days | No | |
| Secondary | Cardiogenic shock | 90 days | No | |
| Secondary | Reinfarction | 90 days | No | |
| Secondary | Repeat target vessel revascularisation (TVR) | 90 days | No | |
| Secondary | Rehospitalisation for congestive heart failure | 90 days | No | |
| Secondary | Rehospitalisation for cardiogenic shock | 90 days | No | |
| Secondary | Rehospitalisation for other cardiac reasons | 90 days | No | |
| Secondary | Congestive heart failure | 90 days | No | |
| Secondary | N-terminal pro-brain natriuretic peptide (NT pro-BNP) | 90 days | No | |
| Secondary | Disabling stroke | 90 days | No | |
| Secondary | Total stroke | 90 days | No | |
| Secondary | Rehospitalisation for stroke or ICH (intrancranial haemorrhage) | 90 days | No |
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