Status:
COMPLETED
Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Disease
Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
Detailed Description
Thrombin plays a major role in acute coronary artery occlusions during percutaneous coronary interventions. Unfractionated heparin has been traditionally used during invasive coronary procedures to re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
4570 Patients enrolled
Trial Details
Trial ID
NCT00262054
Start Date
November 1 2005
End Date
May 1 2008
Last Update
March 15 2010
Active Locations (4)
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1
Herz-Zentrum
Bad Krozingen, Germany, 79189
2
Segeberger Kliniken
Bad Segeberg, Germany, 23795
3
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
4
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675