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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Death or cardiogenic shock or congestive heart failure within 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1671
Study Start Date: November 2003
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 177 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Genentech, Inc.
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168792     History of Changes
Other Study ID Numbers: 1123.12
Study First Received: September 9, 2005
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Calcium heparin
Heparin
Tenecteplase
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014