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
Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 13, 2010
July 1, 2010
1.5 years
July 6, 2010
July 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
death at 30 days
1 month
stent thrombosis
1 year
target vessel failure
1 year
re-acute myocardial infarction
1 month
Secondary Outcomes (3)
bleeding
1 month
timi frame count
1 day
vascular site access complications
1 month
Study Arms (1)
multivessel revascularization
EXPERIMENTALComplete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure
Interventions
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00151, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 13, 2010
Study Start
July 1, 2010
Primary Completion
January 1, 2012
Study Completion
July 1, 2012
Last Updated
July 13, 2010
Record last verified: 2010-07