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Antithrombotic Regimens and Outcome (ARNO)

This study has been completed.
Sponsor:
Information provided by:
Careggi Hospital
ClinicalTrials.gov Identifier:
NCT00448461
First received: March 14, 2007
Last updated: February 9, 2009
Last verified: February 2009
  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
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:

  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
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: 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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Bivalirudin
Calcium heparin
Heparin
Anticoagulants
Antithrombins
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014