Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine which of these anti-clotting medications, abciximab plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and bleeding complications in patients suffering from a heart attack and undergoing coronary intervention.

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

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Abciximab; Antibodies, Monoclonal; Bivalirudin; Calcium heparin; Heparin; Hirudins; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Episode of unstable angina

• Elevated cardiac markers

• Angiographic lesions requiring PCI

• Informed, written consent

Exclusion Criteria:

• Age < 18 years and > 80 years

• ST-segment elevation acute myocardial infarction within 48 hours

• Cardiogenic shock

• Pericarditis

• Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance

• Active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; pericarditis; and patient's refusal to blood transfusion

• Oral anticoagulation therapy with coumarin derivative within the last 7 days

• Recent use of GPIIb/IIIa inhibitors within 14 days

• Treatment with unfractionated heparin within 4 hours unless ACT > 150sec; or low-molecular weight heparin within 8 hours before randomization

• Treatment with bivalirudin within 24 hours before randomization

• Severe uncontrolled hypertension > 180/110 mm Hg unresponsive to therapy

• Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days

• Relevant hematologic deviations

• Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis

• Known allergy or intolerance to the study medications, stainless steel or true anaphylaxis after prior exposure to contrast media

• Previous enrollment in this trial

• Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding

• Patient's inability to fully cooperate with the study protocol