Myocardial InfarctionPhase 3FITNCT01160900
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.
A Phase 3 study testing Coronary angioplasty all lesions in people with Myocardial Infarction and Ischemia, run by Azienda Ospedaliera San Camillo Forlanini at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Ischemia, Heart Failure
- What is being tested?
- Coronary angioplasty all lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
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.
- Conditions
- Myocardial Infarction, Ischemia, Heart Failure, Necrosis, Stents
- Being tested
- Coronary angioplasty all lesions
- Keywords
- cardiovascular diseases, heart disease, hemorrhage, coronary angioplasty, drug eluting stents
- Medical subject headings
- Myocardial Infarction, Ischemia, Heart Failure, Necrosis, Cardiovascular Diseases, Heart Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angioplasty all lesionsProcedure or surgery
Also called drug eluting stent, prasugrel, bivalirudin
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin
| Study group | Role | What they receive |
|---|---|---|
| multivessel revascularization | Experimental | Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure Receives: Procedure: Coronary angioplasty all lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
death at 30 days
Measured: 1 month
stent thrombosis
Measured: 1 year
target vessel failure
Measured: 1 year
re-acute myocardial infarction
Measured: 1 month
Secondary outcomes (3)
bleeding
Measured: 1 month
timi frame count
Measured: 1 day
vascular site access complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Camillo Forlanini
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160900
- Sponsor's protocol ID
- Sperimental Registry n°844
- Acronym
- FIT
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01160900
- Acronym / sponsor ID
- FIT / Sperimental Registry n°844
- Conditions
- Myocardial Infarction, Ischemia, Heart Failure, Necrosis, Stents
- Keywords
- cardiovascular diseases, heart disease, hemorrhage, coronary angioplasty, drug eluting stents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera San Camillo ForlaniniUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multivessel revascularization | Experimental | Procedure: Coronary angioplasty all lesionsComplete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angioplasty all lesionsAlso: drug eluting stent, prasugrel, bivalirudintreatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin | Procedure or surgery | multivessel revascularization |
Primary outcome
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
3 secondary outcomes
bleeding
Time frame: 1 month
timi frame count
Time frame: 1 day
vascular site access complications
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary angioplasty all lesions in people with Myocardial Infarction and Ischemia, run by Azienda Ospedaliera San Camillo Forlanini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death at 30 days (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2010.