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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1671

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Death or cardiogenic shock or congestive heart failure within 90 days
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2003

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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