NCT00168792|TerminatedPhase 4

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.)

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

1123.12

Study Type

interventional

Target

1,671

Locations

18 countries

Sites

176

Timeline

RegisteredSep 2005

StartedNov 2003

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,671

participants targeted

Target at P75+ for phase_4

Geographic Reach

18 countries

176 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed

Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

2.7 years

First QC Date

September 9, 2005

Last Update Submit

October 28, 2013

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (14)

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
+9 more secondary outcomes

Interventions

TenecteplaseDRUG

PCIPROCEDURE

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

Contact the study team to confirm eligibility.