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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
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. death at 30 days [ Time Frame: 1 month ]
  2. stent thrombosis [ Time Frame: 1 year ]
  3. target vessel failure [ Time Frame: 1 year ]
  4. re-acute myocardial infarction [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. bleeding [ Time Frame: 1 month ]
  2. timi frame count [ Time Frame: 1 day ]
  3. vascular site access complications [ Time Frame: 1 month ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • myocardial acute infarction
  • prolonged chest pain (>20 minute) started less <12 hours before arrive in hospital
  • ST segment elevation of >1mm in >2 contiguous leads
  • new left bundle branch block
  • diameter of the coronary suitable of angioplasty >2mm
  • the patients agrees to the study protocol and provides a written consensus
  • two or more coronary suitable for angioplasty

Exclusion Criteria:

  • refused written consensus
  • hypersensitivity or contraindication to any of the following medications: heparin bivalirudin aspirin prasugrel stainless steel
  • history of bleeding
  • cardiogenic shock (PA < 90mmHg)
  • chronic total occlusion in the second lesion
  • TIMI Flow < II in the culprit lesion
  • recent pregnancy
  • history of intra-cerebral major hemorrhagic stroke
  • an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment life expectancy <1 year
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00151
Sponsors and Collaborators
Azienda Ospedaliera San Camillo Forlanini
More Information

Responsible Party: Interventional Cardiology, A O San Camillo Forlanini Rome, Marco Stefano Nazzaro
ClinicalTrials.gov Identifier: NCT01160900     History of Changes
Other Study ID Numbers: Sperimental Registry n°844
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: July 13, 2010
Last Verified: July 2010

Keywords provided by Azienda Ospedaliera San Camillo Forlanini:
cardiovascular diseases
heart disease
hemorrhage
coronary angioplasty
drug eluting stents

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Ischemia
Necrosis
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Prasugrel Hydrochloride
Bivalirudin
Platelet Aggregation Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants