Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study has been terminated.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00168792
First received: September 9, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Tenecteplase
Procedure: PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Death or cardiogenic shock or congestive heart failure within 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death or cardiogenic shock or congestive heart failure within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cardiogenic shock or congestive heart failure within 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Cardiogenic shock [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Reinfarction [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Repeat target vessel revascularisation (TVR) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for congestive heart failure [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for cardiogenic shock [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for other cardiac reasons [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Congestive heart failure [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • N-terminal pro-brain natriuretic peptide (NT pro-BNP) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Disabling stroke [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Total stroke [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for stroke or ICH (intrancranial haemorrhage) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1671
Study Start Date: November 2003
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168792

  Hide Study Locations
Locations
United States, Arkansas
Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Georgia
Boehringer Ingelheim Investigational Site
Macan, Georgia, United States
United States, Michigan
Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Nebraska
Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, Rhode Island
Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
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, Austria
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, Belgium
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, Brazil
Canada, British Columbia
Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, Ontario
Boehringer Ingelheim Investigational Site
Saint-Foy, Ontario, Canada
Boehringer Ingelheim Investigational Site
Sudbury, Ontario, Canada
Canada, Quebec
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Canada, Saskatchewan
Boehringer Ingelheim Investigational Site
Regina, Saskatchewan, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Czech Republic
Boehringer Ingelheim Investigational Site
Pardubice, Czech Republic
Boehringer Ingelheim Investigational Site
Prague 4-Krc, Czech Republic
Boehringer Ingelheim Investigational Site
Prague 5, Czech Republic
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, France
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
Bonn, Germany
Boehringer Ingelheim Investigational Site
Boppard, Germany
Boehringer Ingelheim Investigational Site
Bremen, Germany
Boehringer Ingelheim Investigational Site
Böblingen, 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
Korbach, Germany
Boehringer Ingelheim Investigational Site
Köln, 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
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, Germany
Boehringer Ingelheim Investigational Site
Öhringen, Germany
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, Greece
Hungary
Boehringer Ingelheim Investigational Site
Balatonfüred, Hungary
Boehringer Ingelheim Investigational Site
Budapest, Hungary
Boehringer Ingelheim Investigational Site
Debrecen, Hungary
Boehringer Ingelheim Investigational Site
Pécs, Hungary
Ireland
Boehringer Ingelheim Investigational Site
Galway, Ireland
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), Italy
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., Mexico
Norway
Boehringer Ingelheim Investigational Site
Bergen, Norway
Boehringer Ingelheim Investigational Site
Oslo, Norway
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, Poland
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, Portugal
Thailand
Boehringer Ingelheim Investigational Site
Bangkok, Thailand
Boehringer Ingelheim Investigational Site
Chiangmai, Thailand
Turkey
Boehringer Ingelheim Investigational Site
Ankara, Turkey
Boehringer Ingelheim Investigational Site
Istanbul, Turkey
Boehringer Ingelheim Investigational Site
Izmir, Turkey
Sponsors and Collaborators
Boehringer Ingelheim
Genentech, Inc.
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168792     History of Changes
Other Study ID Numbers: 1123.12
Study First Received: September 9, 2005
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Calcium heparin
Heparin
Tenecteplase
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014