Clinical trial NCT00828087: A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study
Official title: A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: acute myocardial infarction
primary percutaneous coronary intervention
drug-eluting stent
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 1504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year.
timeFrame: 1 year
Secondary outcomes:
measure: All cause and cardiac mortality
timeFrame: at 1 year and yearly up to 5 years
measure: Recurrent myocardial infarction
timeFrame: at 1 year and yearly up to 5 years
measure: Target lesion revascularization
timeFrame: at 1 year and yearly up to 5 years
measure: Target vessel revascularization
timeFrame: at 1 year and yearly up to 5 years
measure: Stent thrombosis
timeFrame: at 1 year and yearly up to 5 years
measure: Clinical device success
timeFrame: Procedure moment
measure: Clinical procedure success
timeFrame: procedure moment
measure: Major and minor bleeding
timeFrame: at 1 year and yearly up to 5 years
Other outcomes:
Locations:
city: Seriate
country: Italy
facility: Azienda Ospedaliera Bolognini
state: Bergamo
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria S. Anna di Ferrara
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Rotterdam
city: A Coruña
country: Spain
facility: Complejo Hospitalario U. A Coruña
state: A Croruña
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
state: Baleares
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
Study officials:
affiliation: Erasmus MC, Rotterdam
name: Prof. P.W. Serruys, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic i Provincial de Barcelona
name: Manuel Sabate, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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