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:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Genentech
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00168792
First received: September 9, 2005
Last updated: May 18, 2012
Last verified: May 2012
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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. |
Resource links provided by NLM:
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
Show 177 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Genentech
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
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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: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Calcium heparin Heparin |
Tenecteplase Tissue Plasminogen Activator Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013