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.

Heart Failure Clinical Trial

— FIT  

Official title:

Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01160900
• Other study ID #: Sperimental Registry n°844
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 6, 2010
• Last updated: July 12, 2010
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2010
• Source: Azienda Ospedaliera San Camillo Forlanini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Ischemia
• Myocardial Infarction
• Necrosis
• Stents

Intervention

Procedure:
• Coronary angioplasty all lesions
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Camillo Forlanini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death at 30 days		1 month	Yes
Primary	stent thrombosis		1 year	Yes
Primary	target vessel failure		1 year	Yes
Primary	re-acute myocardial infarction		1 month	Yes
Secondary	bleeding		1 month	Yes
Secondary	timi frame count		1 day	No
Secondary	vascular site access complications		1 month	Yes