September 13, 2005 |
July 2, 2007 |
May 2003 |
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 ] |
Same as current |
Complete list of historical versions of study NCT00220571 on ClinicalTrials.gov Archive Site |
- 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 ]
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- 1. Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two
arms;
- 2. 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
- 3. Compare the incidence of in-hospital stroke and bleeding complications in the two arms.
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CARESS in Acute Myocardial Infarction |
Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction |
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
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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. |
Phase III |
Interventional |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Myocardial Infarction |
Device: Coronary Angioplasty (PTCA) |
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Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A, Guiducci V, Patrizi G, Rusconi LC, Piovaccari G, Hibon AR, Belpomme V, Indolfi C, Olivari Z, Steffenino G, Zmudka K, Airoldi F, Panzarasa R, Flather M, Steg PG. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J. 2004 Sep;148(3):378-85. |
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Completed |
600 |
March 2007 |
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Inclusion Criteria:
Exclusion Criteria:
- Inability to provide informed consent;
- Age > 75 years
- CABG or PCI procedure in past history involving the infarct-related artery;
- Participation in another study with any investigational drug or device within the previous 30 days;
- Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
- 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);
- 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);
- Severe hepatic disease;
- Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min);
- Transmural MI in different location within the previous week;
- Previous administration of thrombolytics within 7 days;
- Intolerance or contraindications to ASA or Clopidogrel;
- Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
- Known neutropenia, defined as < 1000 neutrophils / ml;
- Known thrombocytopenia (< 100.000 platelets / ml );
- Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
- Previous hemorrhagic stroke;
- Previous ischemic cerebrovascular event within 3 months;
- Intracranial neoplasm;
- Recent major surgery at risk of bleeding;
- Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years;
- Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
- Severe recent trauma;
- Known or possible pregnancy;
- Absence of suitable vascular access (diffuse peripheral arterial disease);
- Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).
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Both |
up to 75 Years |
No |
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France, Italy, Poland |
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NCT00220571 |
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2003OE001B |
Società Italiana di Cardiologia Invasiva |
- Royal Brompton Hospital NHS Trust
- Eli Lilly and Company
- Biotronik GmbH & Co. KG
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Principal Investigator: |
Leonardo Bolognese, MD, Ph D |
Ospedale San Donato - Arezzo Italy |
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Principal Investigator: |
Gabriel P. Steg, MD. Ph D |
Hopital Bichat - Paris France |
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Principal Investigator: |
Darius Dudek, MD, Ph D |
Jagellonian University Krakow Poland |
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Study Chair: |
Carlo Di Mario, MD |
Royal Brompton and Harefield Hospital - London UK |
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Società Italiana di Cardiologia Invasiva |
September 2005 |