A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study

Myocardial Infarction Clinical Trial

Official title:

A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828087
• Other study ID #: EXAM-08
• Status: Completed
• Phase: N/A
• First received: January 22, 2009
• Last updated: May 18, 2015
• Start date: December 2008
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

Description:

Primary PCI, with or without stenting, has been shown to result in superior long-term outcome when compared to thrombolytic therapy in patients with acute myocardial infarction (MI).

Recently, several studies showed that both sirolimus- and paclitaxel-eluting stents are more effective in reducing restenosis and the frequency of repeat interventions than bare metal stents, which rapidly resulted in an unrestricted use of drug-eluting stents, also in patients with ST segment elevation MI (STEMI). , , , Shortly after the introduction of the sirolimus-eluting stent in April 2002 the first studies appeared, hypothesizing that the therapeutic range of sirolimus-eluting stents could be extended to patients presenting with MI. When compared to bare metal stents, sirolimus-eluting stents were associated with less restenosis and target vessel revascularization (TVR) up until one year of follow-up. , At present, it is unclear whether this also holds for paclitaxel-eluting stents.4,

Everolimus is a sirolimus analogue, an effective anti-proliferative agent that inhibits growth factor-stimulated cell proliferation by causing cell cycle arrest in the late G1 stage in the cell cycle.

The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

The primary endpoint is the combined endpoint of Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year (patient oriented endpoint suggested by the ARC definitions).

The following secondary endpoints will be examined:

• All cause and cardiac mortality at 1 year and yearly up to 5 years.

• Recurrent myocardial infarction at 1 year and yearly up to 5 years.

• Target lesion revascularization at 1 year and yearly up to 5 years.

• Target vessel revascularization at 1 year and yearly up to 5 years.

• Stent thrombosis (according to the new definitions proposed by the Academic Research Consortium) at 1 year and yearly up to 5 years.

• Clinical device success

• Clinical procedure success.

• Major and minor bleeding at 1 year and yearly up to 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1504
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following criteria

• Patients presenting with a ST-elevation myocardial infarction <12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation

• Cardiogenic shock.

• Rescue PCI after failed thrombolysis.

• PCI indicated early (<24h) after effective thrombolysis following current ESC guidelines.

• Patients presenting late ("latecomers") with ST-elevation myocardial infarction (>12h-48h) after the onset of symptoms.

• Written informed consent.

• The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.

Angiographic:

• Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.

Exclusion Criteria:

• Age < 18 years.

• Pregnancy or breastfeeding.

• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.

• Patients with absolute indication of being chronic treated with acenocoumarol

• Myocardial infarction due to a previously implanted stent thrombosis

• Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

Device:
• cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria S. Anna di Ferrara	Ferrara
Italy	Azienda Ospedaliera Bolognini	Seriate	Bergamo
Netherlands	Erasmus MC, Rotterdam	Rotterdam
Spain	Complejo Hospitalario U. A Coruña	A Coruña	A Croruña
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Son Dureta	Palma de Mallorca	Baleares
Spain	Hospital do Meixoeiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Countries where clinical trial is conducted

Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year.		1 year	Yes
Secondary	All cause and cardiac mortality		at 1 year and yearly up to 5 years	Yes
Secondary	Recurrent myocardial infarction		at 1 year and yearly up to 5 years	No
Secondary	Target lesion revascularization		at 1 year and yearly up to 5 years	No
Secondary	Target vessel revascularization		at 1 year and yearly up to 5 years	No
Secondary	Stent thrombosis		at 1 year and yearly up to 5 years	Yes
Secondary	Clinical device success	?Successful delivery and deployment of the first inserted stent and a final diameter stenosis after stenting = 50% by QCA or visual assessment.	Procedure moment	No
Secondary	Clinical procedure success	Successful delivery and deployment of study stent in the target lesion and successful removal of the stent delivery system with a final diameter stenosis after stenting = 50% by QCA or visual assessment without the occurrence of serious cardiac events important for ischemia during hospitalization, with a maximum of seven days after the initial procedure.	procedure moment	Yes
Secondary	Major and minor bleeding		at 1 year and yearly up to 5 years	Yes