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)

October 28, 2013 updated by: Boehringer Ingelheim

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.)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1671

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Pölten, Austria
        • Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site
      • Wr. Neustadt, Austria
        • Boehringer Ingelheim Investigational Site
  • Belgium
      • 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
        • Boehringer Ingelheim Investigational Site
  • Brazil
      • 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
        • Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada
        • Boehringer Ingelheim Investigational Site
    • Ontario
      • Saint-Foy, Ontario, Canada
        • Boehringer Ingelheim Investigational Site
      • Sudbury, Ontario, Canada
        • Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Boehringer Ingelheim Investigational Site
      • Saskatoon, Saskatchewan, Canada
        • Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Pardubice, Czech Republic
        • Boehringer Ingelheim Investigational Site
      • Prague 4-Krc, Czech Republic
        • Boehringer Ingelheim Investigational Site
      • Prague 5, Czech Republic
        • Boehringer Ingelheim Investigational Site
  • France
      • 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
        • Boehringer Ingelheim Investigational Site
  • Germany
      • 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
        • Boehringer Ingelheim Investigational Site
  • Greece
      • 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
        • Boehringer Ingelheim Investigational Site
  • Hungary
      • Balatonfüred, Hungary
        • Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • Boehringer Ingelheim Investigational Site
      • Pécs, Hungary
        • Boehringer Ingelheim Investigational Site
  • Ireland
      • Galway, Ireland
        • Boehringer Ingelheim Investigational Site
  • Italy
      • 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
        • Boehringer Ingelheim Investigational Site
  • Mexico
      • 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
        • Boehringer Ingelheim Investigational Site
      • col. Doctores, Mexico
        • Boehringer Ingelheim Investigational Site
  • Norway
      • Bergen, Norway
        • Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • Boehringer Ingelheim Investigational Site
  • Poland
      • 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
        • Boehringer Ingelheim Investigational Site
  • Portugal
      • 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
        • Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand
        • Boehringer Ingelheim Investigational Site
      • Chiangmai, Thailand
        • Boehringer Ingelheim Investigational Site
  • Turkey
      • Ankara, Turkey
        • Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • Boehringer Ingelheim Investigational Site
      • Izmir, Turkey
        • Boehringer Ingelheim Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Boehringer Ingelheim Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • Boehringer Ingelheim Investigational Site
    • Georgia
      • Macan, Georgia, United States
        • Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death or cardiogenic shock or congestive heart failure within 90 days
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 90 days
90 days
Death or cardiogenic shock or congestive heart failure within 30 days
Time Frame: 30 days
30 days
Cardiogenic shock or congestive heart failure within 90 days
Time Frame: 90 days
90 days
Cardiogenic shock
Time Frame: 90 days
90 days
Reinfarction
Time Frame: 90 days
90 days
Repeat target vessel revascularisation (TVR)
Time Frame: 90 days
90 days
Rehospitalisation for congestive heart failure
Time Frame: 90 days
90 days
Rehospitalisation for cardiogenic shock
Time Frame: 90 days
90 days
Rehospitalisation for other cardiac reasons
Time Frame: 90 days
90 days
Congestive heart failure
Time Frame: 90 days
90 days
N-terminal pro-brain natriuretic peptide (NT pro-BNP)
Time Frame: 90 days
90 days
Disabling stroke
Time Frame: 90 days
90 days
Total stroke
Time Frame: 90 days
90 days
Rehospitalisation for stroke or ICH (intrancranial haemorrhage)
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion

July 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1123.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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