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| 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. |
| 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 |
Inclusion Criteria:
(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI)
Exclusion Criteria: None
Contacts and Locations
Show 177 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| 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 |
|
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 |