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Tracking Information | |||||
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First Received Date † | February 28, 2008 | ||||
Last Updated Date | December 29, 2008 | ||||
Start Date † | January 2005 | ||||
Current Primary Outcome Measures † |
ST segment regression 1 hour after angioplasty [ Time Frame: 1 hour after angioplasty ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00638638 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Major cardiac events at 1 and 6 month [ Time Frame: 1 and 6 month ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Myocardial Infarction With ST-Elevation | ||||
Official Title † | Myocardial Infarction With ST-Elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace. | ||||
Brief Summary | Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Myocardial Infarction | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 292 | ||||
Estimated Completion Date | January 2010 | ||||
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00638638 | ||||
Responsible Party | Emmanuel LAVOUE, directeur Adjoint, University Hospital, Strasbourg, France | ||||
Secondary IDs †† | |||||
Study Sponsor † | University Hospital, Strasbourg, France | ||||
Collaborators †† | Eli Lilly and Company | ||||
Investigators † |
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Information Provided By | University Hospital, Strasbourg, France | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |