CARESS in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborators:
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
First received: September 13, 2005
Last updated: July 2, 2007
Last verified: September 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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: 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:
ClinicalTrials.gov Identifier: NCT00220571     History of Changes
Other Study ID Numbers: IIT(IT) H4S-IT-O038, 2003OE001B
Study First Received: September 13, 2005
Last Updated: July 2, 2007
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

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

ClinicalTrials.gov processed this record on October 30, 2014