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.

Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01160900

Acronym

FIT

Enrollment

180

Registered

2010-07-13

Start date

2010-07-31

Completion date

2012-07-31

Last updated

2010-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ischemia, Myocardial Infarction, Necrosis, Stents

Keywords

cardiovascular diseases, heart disease, hemorrhage, coronary angioplasty, drug eluting stents

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.

Interventions

PROCEDURECoronary angioplasty all lesions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026