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Antithrombotic Regimens and Outcome (ARNO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00448461
First Posted: March 16, 2007
Last Update Posted: February 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Careggi Hospital
  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:

  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

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
Intervention Model: Parallel Assignment
Masking: None (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
heparin
Drug: heparin
comparison between heparin and bivalirudin
Active Comparator: 2
bivalirudin
Drug: bivalirudin
comparison between heparin and bivalirudin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: David Antoniucci, Division of Cardiology, Careggi Hospital, Florence, Italy
ClinicalTrials.gov Identifier: NCT00448461     History of Changes
Other Study ID Numbers: arcard2007/001
First Submitted: March 14, 2007
First Posted: March 16, 2007
Last Update Posted: February 10, 2009
Last Verified: February 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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Bivalirudin
Heparin
Hirudins
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors