FIT (Fast Infarction Treatment): Complete Revascularizati... | NCT01160900

Studies
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.

NCT01160900

Sponsor

Azienda Ospedaliera San Camillo Forlanini

Status

Unknown status

Last Update Posted

Jul 13, 2010Estimated

Enrollment

180Estimated

Phase

Phase 3

Conditions

Myocardial Infarction
Ischemia
Heart Failure
Necrosis
Stents

Interventions

Coronary angioplasty all lesions

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jan 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 12, 2010

First Posted Date

Jul 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2010

Last Update Posted Date

Jul 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multivessel revascularization	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coronary angioplasty all lesions	Procedure	treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin	multivessel revascularization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death at 30 days		1 month
stent thrombosis		1 year
target vessel failure		1 year
re-acute myocardial infarction		1 month

Secondary Outcomes

Measure	Description	Time Frame
bleeding		1 month
timi frame count		1 day
vascular site access complications

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera San Camillo Forlanini		Roma	Italy	00151	Italy

ID	Term
D009203	Myocardial Infarction
D007511	Ischemia
D006333	Heart Failure
D009336	Necrosis
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D006470	Hemorrhage

ID	Term
D017202	Myocardial Ischemia
D014652	Vascular Diseases
D007238	Infarction
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D054855	Drug-Eluting Stents
D000068799	Prasugrel Hydrochloride
C074619	bivalirudin

ID	Term
D015607	Stents
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds