NCT00448461

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

March 14, 2007

Last Update Submit

February 9, 2009

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasepercutaneous coronary interventions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be in-hospital major bleeding.

    30 days

Secondary Outcomes (6)

  • Composite rate of death, myocardial infarction (MI) or urgent

    6 months

  • target vessel revascularization (TVR) inhospital, and at 6 months

    6 months

  • Composite rate of inhospital death, MI or TVR and major bleeding

    6 months

  • Major and minor bleedings

    6 months

  • Total vascular complications

    6 months

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

heparin

Drug: heparin

2

ACTIVE COMPARATOR

bivalirudin

Drug: bivalirudin

Interventions

heparinDRUG

comparison between heparin and bivalirudin

1
bivalirudinDRUG

comparison between heparin and bivalirudin

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Careggi Hospital

Florence, 50141, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Heparinbivalirudin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • David Antoniucci, MD

    Division of Cardiology, Careggi Hospital, Florence, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 16, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

IT(1)