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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Sabate, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00828087
First received: January 22, 2009
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Myocardial Infarction
Drug: Everolimus Eluting Coronary Stent System
Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study

Resource links provided by NLM:


Further study details as provided by Spanish Society of Cardiology:

Primary Outcome Measures:
  • Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause and cardiac mortality [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Recurrent myocardial infarction [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Clinical device success [ Time Frame: Procedure moment ] [ Designated as safety issue: No ]
    Successful delivery and deployment of the first inserted stent and a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment.

  • Clinical procedure success [ Time Frame: procedure moment ] [ Designated as safety issue: Yes ]
    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.

  • Major and minor bleeding [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1504
Study Start Date: December 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus Arm
Everolimus Eluting Coronary Stent System
Drug: Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
Other Name: N/H
Active Comparator: non drug eluting stent Arm
cobalt chromium balloon expandable stent
Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation
Other Name: N/H.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828087

Locations
Italy
Azienda Ospedaliera Bolognini
Seriate, Bergamo, Italy, 24068
Azienda Ospedaliero Universitaria S. Anna di Ferrara
Ferrara, Italy, 44100
Netherlands
Erasmus MC, Rotterdam
Rotterdam, Netherlands, 3015 GD
Spain
Complejo Hospitalario U. A Coruña
A Coruña, A Croruña, Spain, 15006
Hospital Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de Bellvitge
Barcelona, Spain, 08907
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital do Meixoeiro
Vigo, Spain, 36214
Sponsors and Collaborators
Spanish Society of Cardiology
Investigators
Principal Investigator: Prof. P.W. Serruys, MD,PhD Erasmus MC, Rotterdam
Principal Investigator: Manuel Sabate, MD,PhD Hospital Clínic i Provincial de Barcelona
  More Information

No publications provided by Spanish Society of Cardiology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Sabate, Doctor, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00828087     History of Changes
Other Study ID Numbers: EXAM-08
Study First Received: January 22, 2009
Last Updated: July 22, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by Spanish Society of Cardiology:
acute myocardial infarction
primary percutaneous coronary intervention
drug-eluting stent

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Chromium
Everolimus
Sirolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on October 19, 2014