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)
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT00168792
Collaborator
Genentech, Inc. (Industry)
1,671
177
9.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Nov 1, 2003
Primary Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
- Death or cardiogenic shock or congestive heart failure within 90 days [90 days]
Secondary Outcome Measures
- Death or cardiogenic shock or congestive heart failure within 30 days [30 days]
- Cardiogenic shock or congestive heart failure within 90 days [90 days]
- Death [90 days]
- Cardiogenic shock [90 days]
- Reinfarction [90 days]
- Repeat target vessel revascularisation (TVR) [90 days]
- Rehospitalisation for congestive heart failure [90 days]
- Rehospitalisation for cardiogenic shock [90 days]
- Rehospitalisation for other cardiac reasons [90 days]
- Congestive heart failure [90 days]
- N-terminal pro-brain natriuretic peptide (NT pro-BNP) [90 days]
- Disabling stroke [90 days]
- Total stroke [90 days]
- Rehospitalisation for stroke or ICH (intrancranial haemorrhage) [90 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim Investigational Site | Little Rock | Arkansas | United States | |
| 2 | Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States | |
| 3 | Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States | |
| 4 | Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 5 | Boehringer Ingelheim Investigational Site | Macan | Georgia | United States | |
| 6 | Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States | |
| 7 | Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 8 | Boehringer Ingelheim Investigational Site | Providence | Rhode Island | United States | |
| 9 | Boehringer Ingelheim Investigational Site | Feldkirch | Austria | ||
| 10 | Boehringer Ingelheim Investigational Site | St. Pölten | Austria | ||
| 11 | Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 12 | Boehringer Ingelheim Investigational Site | Wr. Neustadt | Austria | ||
| 13 | Boehringer Ingelheim Investigational Site | Aalst | Belgium | ||
| 14 | Boehringer Ingelheim Investigational Site | Antwerpen | Belgium | ||
| 15 | Boehringer Ingelheim Investigational Site | Bonheiden | Belgium | ||
| 16 | Boehringer Ingelheim Investigational Site | Brugge | Belgium | ||
| 17 | Boehringer Ingelheim Investigational Site | Brussel | Belgium | ||
| 18 | Boehringer Ingelheim Investigational Site | Bruxelles / Anderlecht | Belgium | ||
| 19 | Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 20 | Boehringer Ingelheim Investigational Site | Charleroi | Belgium | ||
| 21 | Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 22 | Boehringer Ingelheim Investigational Site | Gent | Belgium | ||
| 23 | Boehringer Ingelheim Investigational Site | Gilly | Belgium | ||
| 24 | Boehringer Ingelheim Investigational Site | Huy | Belgium | ||
| 25 | Boehringer Ingelheim Investigational Site | La Louvière | Belgium | ||
| 26 | Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 27 | Boehringer Ingelheim Investigational Site | Liège-Angleur | Belgium | ||
| 28 | Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 29 | Boehringer Ingelheim Investigational Site | Namur/Bouge | Belgium | ||
| 30 | Boehringer Ingelheim Investigational Site | Namur | Belgium | ||
| 31 | Boehringer Ingelheim Investigational Site | Roeselare | Belgium | ||
| 32 | Boehringer Ingelheim Investigational Site | Blumenau - SC | Brazil | ||
| 33 | Boehringer Ingelheim Investigational Site | Curitiba - PR | Brazil | ||
| 34 | Boehringer Ingelheim Investigational Site | Marília - SP | Brazil | ||
| 35 | Boehringer Ingelheim Investigational Site | Passo Fundo - RS | Brazil | ||
| 36 | Boehringer Ingelheim Investigational Site | Porto Alegre - RS | Brazil | ||
| 37 | Boehringer Ingelheim Investigational Site | São Paulo - SP | Brazil | ||
| 38 | Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada | |
| 39 | Boehringer Ingelheim Investigational Site | Saint-Foy | Ontario | Canada | |
| 40 | Boehringer Ingelheim Investigational Site | Sudbury | Ontario | Canada | |
| 41 | Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 42 | Boehringer Ingelheim Investigational Site | Regina | Saskatchewan | Canada | |
| 43 | Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 44 | Boehringer Ingelheim Investigational Site | Pardubice | Czech Republic | ||
| 45 | Boehringer Ingelheim Investigational Site | Prague 4-Krc | Czech Republic | ||
| 46 | Boehringer Ingelheim Investigational Site | Prague 5 | Czech Republic | ||
| 47 | Boehringer Ingelheim Investigational Site | Aulnay sous Bois | France | ||
| 48 | Boehringer Ingelheim Investigational Site | Brest | France | ||
| 49 | Boehringer Ingelheim Investigational Site | Caen | France | ||
| 50 | Boehringer Ingelheim Investigational Site | Châteauroux | France | ||
| 51 | Boehringer Ingelheim Investigational Site | Clermont-Ferrand | France | ||
| 52 | Boehringer Ingelheim Investigational Site | Colmar | France | ||
| 53 | Boehringer Ingelheim Investigational Site | Créteil | France | ||
| 54 | Boehringer Ingelheim Investigational Site | Lille | France | ||
| 55 | Boehringer Ingelheim Investigational Site | Lorient | France | ||
| 56 | Boehringer Ingelheim Investigational Site | Lyon | France | ||
| 57 | Boehringer Ingelheim Investigational Site | Marseille | France | ||
| 58 | Boehringer Ingelheim Investigational Site | Massy | France | ||
| 59 | Boehringer Ingelheim Investigational Site | Metz | France | ||
| 60 | Boehringer Ingelheim Investigational Site | Montfermeil | France | ||
| 61 | Boehringer Ingelheim Investigational Site | Montpellier | France | ||
| 62 | Boehringer Ingelheim Investigational Site | Nice | France | ||
| 63 | Boehringer Ingelheim Investigational Site | Nîmes | France | ||
| 64 | Boehringer Ingelheim Investigational Site | Paris | France | ||
| 65 | Boehringer Ingelheim Investigational Site | Perpignan | France | ||
| 66 | Boehringer Ingelheim Investigational Site | Pontoise | France | ||
| 67 | Boehringer Ingelheim Investigational Site | Saint Etienne | France | ||
| 68 | Boehringer Ingelheim Investigational Site | Strasbourg | France | ||
| 69 | Boehringer Ingelheim Investigational Site | Bad Friedrichshall | Germany | ||
| 70 | Boehringer Ingelheim Investigational Site | Bad Kreuznach | Germany | ||
| 71 | Boehringer Ingelheim Investigational Site | Bassum | Germany | ||
| 72 | Boehringer Ingelheim Investigational Site | Bautzen | Germany | ||
| 73 | Boehringer Ingelheim Investigational Site | Berlin-Lichtenberg | Germany | ||
| 74 | Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 75 | Boehringer Ingelheim Investigational Site | Bingen | Germany | ||
| 76 | Boehringer Ingelheim Investigational Site | Bonn | Germany | ||
| 77 | Boehringer Ingelheim Investigational Site | Boppard | Germany | ||
| 78 | Boehringer Ingelheim Investigational Site | Bremen | Germany | ||
| 79 | Boehringer Ingelheim Investigational Site | Böblingen | Germany | ||
| 80 | Boehringer Ingelheim Investigational Site | Dresden | Germany | ||
| 81 | Boehringer Ingelheim Investigational Site | Fürstenfeldbruck | Germany | ||
| 82 | Boehringer Ingelheim Investigational Site | Gransee | Germany | ||
| 83 | Boehringer Ingelheim Investigational Site | Hameln | Germany | ||
| 84 | Boehringer Ingelheim Investigational Site | Heidelberg | Germany | ||
| 85 | Boehringer Ingelheim Investigational Site | Jena | Germany | ||
| 86 | Boehringer Ingelheim Investigational Site | Kassel | Germany | ||
| 87 | Boehringer Ingelheim Investigational Site | Kiel | Germany | ||
| 88 | Boehringer Ingelheim Investigational Site | Koblenz | Germany | ||
| 89 | Boehringer Ingelheim Investigational Site | Korbach | Germany | ||
| 90 | Boehringer Ingelheim Investigational Site | Köln | Germany | ||
| 91 | Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 92 | Boehringer Ingelheim Investigational Site | Ludwigsburg | Germany | ||
| 93 | Boehringer Ingelheim Investigational Site | Mannheim | Germany | ||
| 94 | Boehringer Ingelheim Investigational Site | Minden | Germany | ||
| 95 | Boehringer Ingelheim Investigational Site | Möckmühl | Germany | ||
| 96 | Boehringer Ingelheim Investigational Site | Mönchengladbach | Germany | ||
| 97 | Boehringer Ingelheim Investigational Site | München | Germany | ||
| 98 | Boehringer Ingelheim Investigational Site | Offenbach | Germany | ||
| 99 | Boehringer Ingelheim Investigational Site | Paderborn | Germany | ||
| 100 | Boehringer Ingelheim Investigational Site | Ravensburg | Germany | ||
| 101 | Boehringer Ingelheim Investigational Site | Rüdesheim am Rhein | Germany | ||
| 102 | Boehringer Ingelheim Investigational Site | Schwalmstadt | Germany | ||
| 103 | Boehringer Ingelheim Investigational Site | Sömmerda | Germany | ||
| 104 | Boehringer Ingelheim Investigational Site | Wiesbaden | Germany | ||
| 105 | Boehringer Ingelheim Investigational Site | Öhringen | Germany | ||
| 106 | Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 107 | Boehringer Ingelheim Investigational Site | Heraklion | Greece | ||
| 108 | Boehringer Ingelheim Investigational Site | Ioannina | Greece | ||
| 109 | Boehringer Ingelheim Investigational Site | Nea Efkarpia/ Thessaloniki | Greece | ||
| 110 | Boehringer Ingelheim Investigational Site | Nikaea, Piraeus | Greece | ||
| 111 | Boehringer Ingelheim Investigational Site | Rio, Patra | Greece | ||
| 112 | Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 113 | Boehringer Ingelheim Investigational Site | Balatonfüred | Hungary | ||
| 114 | Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 115 | Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 116 | Boehringer Ingelheim Investigational Site | Pécs | Hungary | ||
| 117 | Boehringer Ingelheim Investigational Site | Galway | Ireland | ||
| 118 | Boehringer Ingelheim Investigational Site | Alessandria | Italy | ||
| 119 | Boehringer Ingelheim Investigational Site | Bassano del Grappa | Italy | ||
| 120 | Boehringer Ingelheim Investigational Site | Caserta | Italy | ||
| 121 | Boehringer Ingelheim Investigational Site | Catania | Italy | ||
| 122 | Boehringer Ingelheim Investigational Site | Cremona | Italy | ||
| 123 | Boehringer Ingelheim Investigational Site | Firenze | Italy | ||
| 124 | Boehringer Ingelheim Investigational Site | Genova | Italy | ||
| 125 | Boehringer Ingelheim Investigational Site | Lecce | Italy | ||
| 126 | Boehringer Ingelheim Investigational Site | Lecco | Italy | ||
| 127 | Boehringer Ingelheim Investigational Site | Loreto Mare (NA) | Italy | ||
| 128 | Boehringer Ingelheim Investigational Site | Mantova | Italy | ||
| 129 | Boehringer Ingelheim Investigational Site | Massa | Italy | ||
| 130 | Boehringer Ingelheim Investigational Site | Messina | Italy | ||
| 131 | Boehringer Ingelheim Investigational Site | Mirano (VE) | Italy | ||
| 132 | Boehringer Ingelheim Investigational Site | Monza | Italy | ||
| 133 | Boehringer Ingelheim Investigational Site | Novara | Italy | ||
| 134 | Boehringer Ingelheim Investigational Site | Padova | Italy | ||
| 135 | Boehringer Ingelheim Investigational Site | Palermo | Italy | ||
| 136 | Boehringer Ingelheim Investigational Site | Pesaro | Italy | ||
| 137 | Boehringer Ingelheim Investigational Site | Potenza | Italy | ||
| 138 | Boehringer Ingelheim Investigational Site | Ravenna | Italy | ||
| 139 | Boehringer Ingelheim Investigational Site | Rho (mi) | Italy | ||
| 140 | Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 141 | Boehringer Ingelheim Investigational Site | Salerno | Italy | ||
| 142 | Boehringer Ingelheim Investigational Site | San Donato Milanese | Italy | ||
| 143 | Boehringer Ingelheim Investigational Site | Sassari | Italy | ||
| 144 | Boehringer Ingelheim Investigational Site | Torino | Italy | ||
| 145 | Boehringer Ingelheim Investigational Site | Udine | Italy | ||
| 146 | Boehringer Ingelheim Investigational Site | Varese | Italy | ||
| 147 | Boehringer Ingelheim Investigational Site | Zingonia (bg) | Italy | ||
| 148 | Boehringer Ingelheim Investigational Site | col. Doctores | Mexico | ||
| 149 | Boehringer Ingelheim Investigational Site | Col. Granada | Mexico | ||
| 150 | Boehringer Ingelheim Investigational Site | Col. Magdalena de las Salinas | Mexico | ||
| 151 | Boehringer Ingelheim Investigational Site | Col. Sección XVI, Deleg. | Mexico | ||
| 152 | Boehringer Ingelheim Investigational Site | Col. Valle Verde | Mexico | ||
| 153 | Boehringer Ingelheim Investigational Site | Mèxico, D.F. | Mexico | ||
| 154 | Boehringer Ingelheim Investigational Site | Bergen | Norway | ||
| 155 | Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 156 | Boehringer Ingelheim Investigational Site | Katowice-Ochojec | Poland | ||
| 157 | Boehringer Ingelheim Investigational Site | Katowice | Poland | ||
| 158 | Boehringer Ingelheim Investigational Site | Krakow | Poland | ||
| 159 | Boehringer Ingelheim Investigational Site | Lodz | Poland | ||
| 160 | Boehringer Ingelheim Investigational Site | Lublin | Poland | ||
| 161 | Boehringer Ingelheim Investigational Site | Opole | Poland | ||
| 162 | Boehringer Ingelheim Investigational Site | Poznan | Poland | ||
| 163 | Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 164 | Boehringer Ingelheim Investigational Site | Wroclaw | Poland | ||
| 165 | Boehringer Ingelheim Investigational Site | Zabrze | Poland | ||
| 166 | Boehringer Ingelheim Investigational Site | Almada | Portugal | ||
| 167 | Boehringer Ingelheim Investigational Site | Amadora | Portugal | ||
| 168 | Boehringer Ingelheim Investigational Site | Carnaxide | Portugal | ||
| 169 | Boehringer Ingelheim Investigational Site | Coimbra | Portugal | ||
| 170 | Boehringer Ingelheim Investigational Site | Lisboa | Portugal | ||
| 171 | Boehringer Ingelheim Investigational Site | Porto | Portugal | ||
| 172 | Boehringer Ingelheim Investigational Site | Vila Nova de Gaia | Portugal | ||
| 173 | Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 174 | Boehringer Ingelheim Investigational Site | Chiangmai | Thailand | ||
| 175 | Boehringer Ingelheim Investigational Site | Ankara | Turkey | ||
| 176 | Boehringer Ingelheim Investigational Site | Istanbul | Turkey | ||
| 177 | Boehringer Ingelheim Investigational Site | Izmir | Turkey |
Sponsors and Collaborators
- Boehringer Ingelheim
- Genentech, Inc.
Investigators
- Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00168792
Other Study ID Numbers:
- 1123.12
First Posted:
Sep 15, 2005
Last Update Posted:
Oct 29, 2013
Last Verified:
Oct 1, 2013