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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01160900
Other study ID # Sperimental Registry n°844
Secondary ID
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


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
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