FIT (Fast Infarction Treatment): Complete Revascularization During Primary Percutaneous Coronary Intervention (PCI) Can be Achieved Safely With an Improved Clinical Outcome During the Indexed Hospitalization. (FIT)
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|ClinicalTrials.gov Identifier: NCT01160900|
Recruitment Status : Unknown
Verified July 2010 by Azienda Ospedaliera San Camillo Forlanini.
Recruitment status was: Active, not recruiting
First Posted : July 13, 2010
Last Update Posted : July 13, 2010
Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD).
The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty.
Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Ischemia Heart Failure Necrosis Stents||Procedure: Coronary angioplasty all lesions||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||July 2012|
Experimental: multivessel revascularization
Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure
Procedure: Coronary angioplasty all lesions
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin
Other Name: drug eluting stent, prasugrel, bivalirudin
- death at 30 days [ Time Frame: 1 month ]
- stent thrombosis [ Time Frame: 1 year ]
- target vessel failure [ Time Frame: 1 year ]
- re-acute myocardial infarction [ Time Frame: 1 month ]
- bleeding [ Time Frame: 1 month ]
- timi frame count [ Time Frame: 1 day ]
- vascular site access complications [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160900
|Azienda Ospedaliera San Camillo Forlanini|
|Roma, Italy, 00151|