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Antithrombotic Regimens and Outcome (ARNO)

This study has been completed.
Information provided by:
Careggi Hospital Identifier:
First received: March 14, 2007
Last updated: February 9, 2009
Last verified: February 2009

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:

  1. Composite rate of death, myocardial infarction (MI) or target vessel revascularization (TVR) inhospital, and at 6 months
  2. Composite rate of inhospital death, MI or TVR and major bleeding
  3. Major and minor bleedings
  4. Total vascular complications
  5. Post-procedure renal failure


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.


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
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 ]

Secondary Outcome Measures:
  • Composite rate of death, myocardial infarction (MI) or urgent [ Time Frame: 6 months ]
  • target vessel revascularization (TVR) inhospital, and at 6 months [ Time Frame: 6 months ]
  • Composite rate of inhospital death, MI or TVR and major bleeding [ Time Frame: 6 months ]
  • Major and minor bleedings [ Time Frame: 6 months ]
  • Total vascular complications [ Time Frame: 6 months ]
  • Post-procedure renal failure [ Time Frame: 6 months ]

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
Drug: heparin
comparison between heparin and bivalirudin
Active Comparator: 2
Drug: bivalirudin
comparison between heparin and bivalirudin

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients older than age 18 to undergo PCI
  2. Pretreatment at least 6 hours before PCI with clopidogrel according to the PCI guidelines.
  3. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  1. Recent ST-elevation myocardial infarction within the last 48 hours.
  2. Chronic coronary artery occlusion to be treated
  3. 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.
  4. Active bleeding, bleeding diathesis, recent surgery (< 15 days)
  5. History of gastrointestinal or genitourinary bleeding within the last 6 weeks
  6. Treatment with UFH within 6 hours or low-molecular weight heparin within 8 hours before randomization.
  7. Treatment with bivalirudin within 24 hours beforerandomization.
  8. Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy
  9. Relevant hematologic deviations: hemoglobin < 100 g/L OR platelet count < 100 x 109 /L.
  10. Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis.
  11. Known allergy to the study medications: aspirin, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media.
  12. Known heparin-induced thrombocytopenia
  Contacts and Locations
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Please refer to this study by its identifier: NCT00448461

Division of Cardiology, Careggi Hospital
Florence, Italy, 50141
Sponsors and Collaborators
Careggi Hospital
Study Director: David Antoniucci, MD Division of Cardiology, Careggi Hospital, Florence, Italy
  More Information

Additional Information:
Responsible Party: David Antoniucci, Division of Cardiology, Careggi Hospital, Florence, Italy Identifier: NCT00448461     History of Changes
Other Study ID Numbers: arcard2007/001
Study First Received: March 14, 2007
Last Updated: February 9, 2009

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
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on May 22, 2017