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)

Phase 4

Terminated

• Conditions: Myocardial Infarction

• Registration Number: NCT00168792
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2006-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1671

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Death or cardiogenic shock or congestive heart failure within 90 days	90 days

Secondary Outcome Measures

Name	Time	Method
Rehospitalisation for cardiogenic shock	90 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 congestive heart failure	90 days
Death or cardiogenic shock or congestive heart failure within 30 days	30 days
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

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇹🇷 Izmir, Turkey