Myocardial InfarctionPhase 4NCT00168792

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)

A Phase 4 study testing Tenecteplase and PCI in people with Myocardial Infarction, run by Boehringer Ingelheim at 176 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myocardial Infarction
What is being tested?: Tenecteplase and PCI
Type of treatment: Surgery or procedure
How many people: 1,671 participants
Where: 176 sitesin 18 countries
Study dates: Nov 2003to Jul 2006
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

None listed.

Trial locations and contacts

176 sites in 18 countries.

Country

City, postcode or hospital

176 sites in 18 countries

Germany37 sites

Boehringer Ingelheim Investigational Site
Bad Friedrichshall
Boehringer Ingelheim Investigational Site
Bad Kreuznach
Boehringer Ingelheim Investigational Site
Bassum
Boehringer Ingelheim Investigational Site
Bautzen
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Bingen
Boehringer Ingelheim Investigational Site
Böblingen
Boehringer Ingelheim Investigational Site
Bonn
Boehringer Ingelheim Investigational Site
Boppard
Boehringer Ingelheim Investigational Site
Bremen
Boehringer Ingelheim Investigational Site
Cologne
Boehringer Ingelheim Investigational Site
Dresden
Boehringer Ingelheim Investigational Site
Fürstenfeldbruck
Boehringer Ingelheim Investigational Site
Gransee
Boehringer Ingelheim Investigational Site
Hamelin
Boehringer Ingelheim Investigational Site
Heidelberg
Boehringer Ingelheim Investigational Site
Jena
Boehringer Ingelheim Investigational Site
Kassel
Boehringer Ingelheim Investigational Site
Kiel
Boehringer Ingelheim Investigational Site
Koblenz
Boehringer Ingelheim Investigational Site
Korbach
Boehringer Ingelheim Investigational Site
Leipzig
Boehringer Ingelheim Investigational Site
Lichtenberg
Boehringer Ingelheim Investigational Site
Ludwigsburg
Boehringer Ingelheim Investigational Site
Mannheim
Boehringer Ingelheim Investigational Site
Minden
Boehringer Ingelheim Investigational Site
Möckmühl
Boehringer Ingelheim Investigational Site
Mönchengladbach
Boehringer Ingelheim Investigational Site
München
Boehringer Ingelheim Investigational Site
Offenbach
Boehringer Ingelheim Investigational Site
Öhringen
Boehringer Ingelheim Investigational Site
Paderborn
Boehringer Ingelheim Investigational Site
Ravensburg
Boehringer Ingelheim Investigational Site
Rüdesheim am Rhein
Boehringer Ingelheim Investigational Site
Schwalmstadt
Boehringer Ingelheim Investigational Site
Sömmerda
Boehringer Ingelheim Investigational Site
Wiesbaden

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Italy30 sites

Boehringer Ingelheim Investigational Site
Alessandria
Boehringer Ingelheim Investigational Site
Bassano del Grappa
Boehringer Ingelheim Investigational Site
Caserta
Boehringer Ingelheim Investigational Site
Catania
Boehringer Ingelheim Investigational Site
Cremona
Boehringer Ingelheim Investigational Site
Florence
Boehringer Ingelheim Investigational Site
Genova
Boehringer Ingelheim Investigational Site
Lecce
Boehringer Ingelheim Investigational Site
Lecco
Boehringer Ingelheim Investigational Site
Loreto Mare (NA)
Boehringer Ingelheim Investigational Site
Mantua
Boehringer Ingelheim Investigational Site
Massa
Boehringer Ingelheim Investigational Site
Messina
Boehringer Ingelheim Investigational Site
Mirano (VE)
Boehringer Ingelheim Investigational Site
Monza
Boehringer Ingelheim Investigational Site
Novara
Boehringer Ingelheim Investigational Site
Padova
Boehringer Ingelheim Investigational Site
Palermo
Boehringer Ingelheim Investigational Site
Pesaro
Boehringer Ingelheim Investigational Site
Potenza
Boehringer Ingelheim Investigational Site
Ravenna
Boehringer Ingelheim Investigational Site
Rho (mi)
Boehringer Ingelheim Investigational Site
Roma
Boehringer Ingelheim Investigational Site
Salerno
Boehringer Ingelheim Investigational Site
San Donato Milanese
Boehringer Ingelheim Investigational Site
Sassari
Boehringer Ingelheim Investigational Site
Torino
Boehringer Ingelheim Investigational Site
Udine
Boehringer Ingelheim Investigational Site
Varese
Boehringer Ingelheim Investigational Site
Zingonia (bg)

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France22 sites

Boehringer Ingelheim Investigational Site
Aulnay-sous-Bois
Boehringer Ingelheim Investigational Site
Brest
Boehringer Ingelheim Investigational Site
Caen
Boehringer Ingelheim Investigational Site
Châteauroux
Boehringer Ingelheim Investigational Site
Clermont-Ferrand
Boehringer Ingelheim Investigational Site
Colmar
Boehringer Ingelheim Investigational Site
Créteil
Boehringer Ingelheim Investigational Site
Lille
Boehringer Ingelheim Investigational Site
Lorient
Boehringer Ingelheim Investigational Site
Lyon
Boehringer Ingelheim Investigational Site
Marseille
Boehringer Ingelheim Investigational Site
Massy
Boehringer Ingelheim Investigational Site
Metz
Boehringer Ingelheim Investigational Site
Montfermeil
Boehringer Ingelheim Investigational Site
Montpellier
Boehringer Ingelheim Investigational Site
Nice
Boehringer Ingelheim Investigational Site
Nîmes
Boehringer Ingelheim Investigational Site
Paris
Boehringer Ingelheim Investigational Site
Perpignan
Boehringer Ingelheim Investigational Site
Pontoise
Boehringer Ingelheim Investigational Site
Saint-Etienne
Boehringer Ingelheim Investigational Site
Strasbourg

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Belgium18 sites

Boehringer Ingelheim Investigational Site
Aalst
Boehringer Ingelheim Investigational Site
Anderlecht
Boehringer Ingelheim Investigational Site
Angleur
Boehringer Ingelheim Investigational Site
Antwerp
Boehringer Ingelheim Investigational Site
Bonheiden
Boehringer Ingelheim Investigational Site
Bouge
Boehringer Ingelheim Investigational Site
Bruges
Boehringer Ingelheim Investigational Site
Brussels
Boehringer Ingelheim Investigational Site
Charleroi
Boehringer Ingelheim Investigational Site
Genk
Boehringer Ingelheim Investigational Site
Ghent
Boehringer Ingelheim Investigational Site
Gilly
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Huy
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La Louvière
Boehringer Ingelheim Investigational Site
Leuven
Boehringer Ingelheim Investigational Site
Liège
Boehringer Ingelheim Investigational Site
Namur
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Roeselare

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Poland10 sites

Boehringer Ingelheim Investigational Site
Katowice
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Katowice-Ochojec
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Krakow
Boehringer Ingelheim Investigational Site
Lodz
Boehringer Ingelheim Investigational Site
Lublin
Boehringer Ingelheim Investigational Site
Opole
Boehringer Ingelheim Investigational Site
Poznan
Boehringer Ingelheim Investigational Site
Warsaw
Boehringer Ingelheim Investigational Site
Wroclaw
Boehringer Ingelheim Investigational Site
Zabrze

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United States8 sites

Boehringer Ingelheim Investigational Site
Detroit, Michigan
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
Boehringer Ingelheim Investigational Site
Macan, Georgia
Boehringer Ingelheim Investigational Site
Omaha, Nebraska
Boehringer Ingelheim Investigational Site
Providence, Rhode Island
Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
Boehringer Ingelheim Investigational Site
Tampa, Florida

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Greece7 sites

Boehringer Ingelheim Investigational Site
Athens
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Heraklion
Boehringer Ingelheim Investigational Site
Ioannina
Boehringer Ingelheim Investigational Site
Nea Efkarpia/ Thessaloniki
Boehringer Ingelheim Investigational Site
Nikaea, Piraeus
Boehringer Ingelheim Investigational Site
Rio, Patra
Boehringer Ingelheim Investigational Site
Thessaloniki

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Portugal7 sites

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Almada
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Amadora
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Carnaxide
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Coimbra
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Lisbon
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Porto
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Vila Nova de Gaia

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Brazil6 sites

Boehringer Ingelheim Investigational Site
Blumenau - SC
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Curitiba - PR
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Marília - SP
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Passo Fundo - RS
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Porto Alegre - RS
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São Paulo - SP

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Canada6 sites

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Greater Sudbury, Ontario
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Montreal, Quebec
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Regina, Saskatchewan
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Saint-Foy, Ontario
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Saskatoon, Saskatchewan
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Victoria, British Columbia

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Mexico6 sites

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Col. Doctores
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Col. Granada
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Col. Magdalena de Las Salinas
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Col. Sección XVI, Deleg.
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Col. Valle Verde
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Mèxico, D.F.

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Austria4 sites

Boehringer Ingelheim Investigational Site
Feldkirch
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Sankt Pölten
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Vienna
Boehringer Ingelheim Investigational Site
Wiener Neustadt

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Hungary4 sites

Boehringer Ingelheim Investigational Site
Balatonfüred
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Budapest
Boehringer Ingelheim Investigational Site
Debrecen
Boehringer Ingelheim Investigational Site
Pécs

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Czechia3 sites

Boehringer Ingelheim Investigational Site
Pardubice
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Prague
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Turkey (Türkiye)3 sites

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Ankara
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Istanbul
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Izmir

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Norway2 sites

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Bergen
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Oslo

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Thailand2 sites

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Bangkok
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Chiang Mai

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Ireland1 site

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Galway

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About this study

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.)

Conditions: Myocardial Infarction
Being tested: Tenecteplase, PCI
Medical subject headings: Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TenecteplaseDrug
PCIProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Death or cardiogenic shock or congestive heart failure within 90 days
Measured: 90 days

Secondary outcomes (14)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Jul 2006

First posted15 Sep 2005 (estimated)
Study startNov 2003
Primary completionJul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,671 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00168792
Sponsor's protocol ID: 1123.12
Status last verified: Oct 2013
First submitted: 9 Sep 2005
Last updated: 29 Oct 2013
Results posted: No

Publications

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 myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006 Feb 18;367(9510):569-78. doi: 10.1016/S0140-6736(06)68147-6.
PubMed 16488800
Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: an angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) trial. J Am Coll Cardiol. 2011 May 10;57(19):1867-73. doi: 10.1016/j.jacc.2010.10.061.
PubMed 21545942
Jarai R, Huber K, Bogaerts K, Sinnaeve PR, Ezekowitz J, Ross AM, Zeymer U, Armstrong PW, Van de Werf FJ; ASSENT-4 PCI investigators. Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone [corrected] concentrations in ST elevation myocardial infarction: an analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial. Crit Care Med. 2010 Sep;38(9):1793-801. doi: 10.1097/CCM.0b013e3181eaaf2a.
PubMed 20562693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.)
ClinicalTrials.gov ID: NCT00168792
Acronym / sponsor ID: 1123.12
Conditions: Myocardial Infarction
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 1,671 participants
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Genentech, Inc.
Study start: Nov 2003
Primary completion: Jul 2006
First posted: 15 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tenecteplase	Drug	–
PCI	Procedure or surgery	–

Primary outcome

Death or cardiogenic shock or congestive heart failure within 90 days
Time frame: 90 days

14 secondary outcomes

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

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Results publication: PubMed 16488800Assessment 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 myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006 Feb 18;367(9510):569-78. doi: 10.1016/S0140-6736(06)68147-6.
Derived from this study: PubMed 21545942Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: an angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) trial. J Am Coll Cardiol. 2011 May 10;57(19):1867-73. doi: 10.1016/j.jacc.2010.10.061.
Derived from this study: PubMed 20562693Jarai R, Huber K, Bogaerts K, Sinnaeve PR, Ezekowitz J, Ross AM, Zeymer U, Armstrong PW, Van de Werf FJ; ASSENT-4 PCI investigators. Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone [corrected] concentrations in ST elevation myocardial infarction: an analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial. Crit Care Med. 2010 Sep;38(9):1793-801. doi: 10.1097/CCM.0b013e3181eaaf2a.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Myocardial Infarction

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim Study Coordinator study chair

Boehringer Ingelheim

176 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenecteplase and PCI in people with Myocardial Infarction, run by Boehringer Ingelheim at 176 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in Germany, Italy, France, Belgium, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death or cardiogenic shock or congestive heart failure within 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00168792, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.