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) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

September 24, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

As the main criteria for measuring clinical outcome, the frequency of death, heart failure or cardiogenic shock is compared in the two treatment groups during 90 days after the acute heart attack.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00168792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

As a secondary outcome any other in-hospital complication and bleeds (including intracranial bleeds) are recorded and the frequency compared in the two treatment groups.
Furthermore, intracoronary blood flow measured during catheterisation before and after the PCI and a laboratory blood test (BNP) predicting developing heart failure are compared between the groups.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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.

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarction

Intervention ^ICMJE

Drug: Tenecteplase
Procedure: PCI

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

4000

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Norway, Poland, Portugal, Thailand, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00168792

Responsible Party

Study ID Numbers ^ICMJE

1123.12

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP