Antithrombotic Regimens and Outcome

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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. 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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Careggi Hospital
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

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