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 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.)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168792

Enrollment

1671

Registered

2005-09-15

Start date

2003-11-30

Completion date

Unknown

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Interventions

DRUGTenecteplase

PROCEDUREPCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Death or cardiogenic shock or congestive heart failure within 30 days	30 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
Rehospitalisation for cardiogenic shock	90 days

Countries

Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Norway, Poland, Portugal, Thailand, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026