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CARESS in Acute Myocardial Infarction
This study has been completed.
First Received: September 13, 2005   Last Updated: July 2, 2007   History of Changes
Sponsors and Collaborators: Società Italiana di Cardiologia Invasiva
Royal Brompton & Harefield NHS Foundation Trust
Eli Lilly and Company
Biotronik SE & Co. KG
Information provided by: Società Italiana di Cardiologia Invasiva
ClinicalTrials.gov Identifier: NCT00220571
  Purpose

The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:

  • Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
  • Elective referral for “facilitated” PTCA after early administration of Abciximab and half dose of Reteplase

Condition Intervention Phase
Myocardial Infarction
Device: Coronary Angioplasty (PTCA)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Società Italiana di Cardiologia Invasiva:

Primary Outcome Measures:
  • To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study. [ Time Frame: 30 Day ]

Secondary Outcome Measures:
  • Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms; [ Time Frame: 1 Year ]
  • Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI [ Time Frame: 30 Day and 1 Year ]
  • Compare the incidence of in-hospital stroke and bleeding complications in the two arms. [ Time Frame: 30 Day ]

Enrollment: 600
Study Start Date: May 2003
Study Completion Date: March 2007
Detailed Description:

All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the following criteria of “high risk”:

    1. Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
    2. Previous myocardial infarction (Q- and non Q-wave);
    3. Killip Class 2 or 3;
    4. LV ejection fraction at transthoracic ultrasound < 40%.

Exclusion Criteria:

  1. Inability to provide informed consent;
  2. Age > 75 years
  3. CABG or PCI procedure in past history involving the infarct-related artery;
  4. Participation in another study with any investigational drug or device within the previous 30 days;
  5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
  6. Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg and tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
  7. Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc);
  8. Severe hepatic disease;
  9. Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min);
  10. Transmural MI in different location within the previous week;
  11. Previous administration of thrombolytics within 7 days;
  12. Intolerance or contraindications to ASA or Clopidogrel;
  13. Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
  14. Known neutropenia, defined as < 1000 neutrophils / ml;
  15. Known thrombocytopenia (< 100.000 platelets / ml );
  16. Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
  17. Previous hemorrhagic stroke;
  18. Previous ischemic cerebrovascular event within 3 months;
  19. Intracranial neoplasm;
  20. Recent major surgery at risk of bleeding;
  21. Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years;
  22. Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
  23. Severe recent trauma;
  24. Known or possible pregnancy;
  25. Absence of suitable vascular access (diffuse peripheral arterial disease);
  26. Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220571

  Show 85 Study Locations
Sponsors and Collaborators
Società Italiana di Cardiologia Invasiva
Royal Brompton & Harefield NHS Foundation Trust
Eli Lilly and Company
Biotronik SE & Co. KG
Investigators
Principal Investigator: Leonardo Bolognese, MD, Ph D Ospedale San Donato - Arezzo Italy
Principal Investigator: Gabriel P. Steg, MD. Ph D Hopital Bichat - Paris France
Principal Investigator: Darius Dudek, MD, Ph D Jagellonian University Krakow Poland
Study Chair: Carlo Di Mario, MD Royal Brompton and Harefield Hospital - London UK
  More Information

Publications:
Study ID Numbers: IIT(IT) H4S-IT-O038, 2003OE001B
Study First Received: September 13, 2005
Last Updated: July 2, 2007
ClinicalTrials.gov Identifier: NCT00220571     History of Changes
Health Authority: Italy: Ministry of Health;   France: Ministry of Health;   Poland: Ministry of Health

Keywords provided by Società Italiana di Cardiologia Invasiva:
AMI
stent
PTCA
abciximab
reteplase
combo therapy

Study placed in the following topic categories:
Necrosis
Heart Diseases
Reteplase
Myocardial Ischemia
Vascular Diseases
Abciximab
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 11, 2009