Overview

This trial is active, not recruiting.

Conditions myocardial infarction, ischemia, heart failure, necrosis, stents
Treatment coronary angioplasty all lesions
Phase phase 3
Sponsor Azienda Ospedaliera San Camillo Forlanini
Start date July 2010
End date January 2012
Trial size 180 participants
Trial identifier NCT01160900, Sperimental Registry n°844

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure
coronary angioplasty all lesions drug eluting stent, prasugrel, bivalirudin
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin

Primary Outcomes

Measure
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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera San Camillo Forlanini.