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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.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Azienda Ospedaliera San Camillo Forlanini.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera San Camillo Forlanini
ClinicalTrials.gov Identifier:
NCT01160900
First received: July 6, 2010
Last updated: July 12, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarction
Ischemia
Heart Failure
Necrosis
Stents
 Procedure: Coronary angioplasty all lesions
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction

Resource links provided by NLM:

Drug Information available for: Bivalirudin
U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera San Camillo Forlanini:

Primary Outcome Measures:
  • death at 30 days [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • target vessel failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • re-acute myocardial infarction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • timi frame count [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • vascular site access complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160900

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

No publications provided

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
Study First Received: July 6, 2010
Last Updated: July 12, 2010
Health Authority: Italy: National Institute of Health

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
Ischemia
Myocardial Infarction
Necrosis
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Bivalirudin
Prasugrel
Antithrombins
Serine Proteinase Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013