Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.

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

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

Inclusion Criteria:

• Patients older than 18 years of age to undergo PCI

• Clopidogrel loading at least 2 hrs prior to PCI according to the PCI guidelines

• Informed, written consent

Exclusion Criteria:

• Recent ST-elevation myocardial infarction within the last 48 hours

• Cardiogenic shock

• ACS and positive biomarkers (Troponin T > 0.03 µg/L)

• 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

• History of gastrointestinal or genitourinary bleeding within the last 6 weeks

• Presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis

• Recent trauma or major surgery in the last month

• Ophthalmic surgery or brain surgery in the last month

• Retinopathies or vitreous body bleeding in the last month

• History of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)

• Suspected aortic dissection; pericarditis and subacute bacterial endocarditis

• Patient's refusal to blood transfusion

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

• Treatment with UFH within 6 hours or low-molecular weight heparin within 8 hours before randomization

• Treatment with bivalirudin within 24 hours before randomization

• Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy

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

• Relevant hematologic deviations:hemoglobin < 100 g/L; 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 (Typ II)

• Previous enrollment in this trial

• Pregnancy (present, suspected or planned) or positive pregnancy test

• Spinal, peridural and epidural anesthesia

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