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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.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00168792
First received: September 9, 2005
Last updated: October 28, 2013
Last verified: October 2013

September 9, 2005
October 28, 2013
November 2003
July 2006   (final data collection date for primary outcome measure)
Death or cardiogenic shock or congestive heart failure within 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00168792 on ClinicalTrials.gov Archive Site
  • Death or cardiogenic shock or congestive heart failure within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cardiogenic shock or congestive heart failure within 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Cardiogenic shock [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Reinfarction [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Repeat target vessel revascularisation (TVR) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for congestive heart failure [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for cardiogenic shock [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for other cardiac reasons [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Congestive heart failure [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • N-terminal pro-brain natriuretic peptide (NT pro-BNP) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Disabling stroke [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Total stroke [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for stroke or ICH (intrancranial haemorrhage) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
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.)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Tenecteplase
  • Procedure: PCI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1671
Not Provided
July 2006   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Mexico,   Norway,   Poland,   Portugal,   Thailand,   Turkey
 
NCT00168792
1123.12
Not Provided
Not Provided
Boehringer Ingelheim
Genentech, Inc.
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
October 2013

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