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)

This study has been terminated.

First Received: September 9, 2005 Last Updated: September 24, 2009 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Collaborator:	Genentech
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00168792

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: Tenecteplase Procedure: PCI	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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.

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Heart Attack Heart Failure

Drug Information available for: Tenecteplase Heparin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	4000
Study Start Date:	November 2003
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168792

Show 177 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Genentech

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	1123.12
Study First Received:	September 9, 2005
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00168792 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Diseases
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Heparin, Low-Molecular-Weight
Hematologic Agents
Vascular Diseases
Tenecteplase
Fibrinolytic Agents
Cardiovascular Agents

Ischemia
Pharmacologic Actions
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on February 08, 2010