Antithrombotic Regimens and Outcome (ARNO)
This study has been completed.
Sponsor:
Careggi Hospital
Information provided by:
Careggi Hospital
ClinicalTrials.gov Identifier:
NCT00448461
First received: March 14, 2007
Last updated: February 9, 2009
Last verified: February 2009
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Purpose
PROTOCOL SYNOPSIS Title: Comparison of bivalirudin and unfractioned heparin (UFH)+ protamine in elective percutaneous coronary interventions (PCI)
Design: Prospective, randomized, controlled trial
Hypothesis: Bivalirudin is superior to UFH + protamine for the improvement of outcomes in patients undergoing elective PCI
Key Inclusion Criteria:
Patients older than 18 years of age to undergo PCI Clopidogrel loading > 6 hrs prior to PCI according to the PCI guidelines Informed, written consent
Key Exclusion Criteria:
ST-elevation myocardial infarction within the prior 48 hours Active bleeding, bleeding diathesis, recent surgery Severe renal failure Chronic coronary artery occlusion to be treated
Primary endpoint:
Inhospital major bleeding
Secondary endpoints:
- Composite rate of death, myocardial infarction (MI) or target vessel revascularization (TVR) inhospital, and at 6 months
- Composite rate of inhospital death, MI or TVR and major bleeding
- Major and minor bleedings
- Total vascular complications
- Post-procedure renal failure
Randomization:
Bivalirudin versus unfractioned heparin followed by protamine at the end of the PCI procedure
Sample size:
Assumed incidence of inhospital major bleeding of 6% in UFH + protamine and of 2% in bivalirudin group; for a power of 80% and a level of 0.05 for each group 425 patients are needed. An interim analysis will be performed after the enrolment of 425 (50%) patients.
Follow-up:
Inhospital, and 6-month clinical follow-up (out-patient clinic or by phone)
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: heparin Drug: bivalirudin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Bivalirudin and Unfractioned Heparin in Elective Percutaneous Coronary Interventions |
Resource links provided by NLM:
Further study details as provided by Careggi Hospital:
Primary Outcome Measures:
- The primary outcome measure will be in-hospital major bleeding. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Composite rate of death, myocardial infarction (MI) or urgent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- target vessel revascularization (TVR) inhospital, and at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Composite rate of inhospital death, MI or TVR and major bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Major and minor bleedings [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Total vascular complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Post-procedure renal failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 850 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
heparin
|
Drug: heparin
comparison between heparin and bivalirudin
|
|
Active Comparator: 2
bivalirudin
|
Drug: bivalirudin
comparison between heparin and bivalirudin
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients older than age 18 to undergo PCI
- Pretreatment at least 6 hours before PCI with clopidogrel according to the PCI guidelines.
- Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Exclusion Criteria:
- Recent ST-elevation myocardial infarction within the last 48 hours.
- Chronic coronary artery occlusion to be treated
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance.
- Active bleeding, bleeding diathesis, recent surgery (< 15 days)
- History of gastrointestinal or genitourinary bleeding within the last 6 weeks
- Treatment with UFH within 6 hours or low-molecular weight heparin within 8 hours before randomization.
- Treatment with bivalirudin within 24 hours beforerandomization.
- Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy
- Relevant hematologic deviations: hemoglobin < 100 g/L OR platelet count < 100 x 109 /L.
- Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis.
- Known allergy to the study medications: aspirin, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
- Known heparin-induced thrombocytopenia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448461
Locations
| Italy | |
| Division of Cardiology, Careggi Hospital | |
| Florence, Italy, 50141 | |
Sponsors and Collaborators
Careggi Hospital
Investigators
| Study Director: | David Antoniucci, MD | Division of Cardiology, Careggi Hospital, Florence, Italy |
More Information
Additional Information:
No publications provided
| Responsible Party: | David Antoniucci, Division of Cardiology, Careggi Hospital, Florence, Italy |
| ClinicalTrials.gov Identifier: | NCT00448461 History of Changes |
| Other Study ID Numbers: | arcard2007/001 |
| Study First Received: | March 14, 2007 |
| Last Updated: | February 9, 2009 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Careggi Hospital:
|
coronary artery disease percutaneous coronary interventions |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Calcium heparin Bivalirudin Heparin Hirudins |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013