Status:
COMPLETED
Reduced Dose of Unfractionated Heparin in Patients Undergoing PCI
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this trial is to evaluate whether a reduction in the heparin dose from 140 to 100 U/kg is associated with a better net clinical outcome in patients undergoing PCI after pretreatment with 60...
Detailed Description
Percutaneous coronary interventions, mostly with implantation of bare-metal or drug-eluting stents, are commonly used to treat patients with coronary artery disease. Various periprocedural adjunct ant...
Eligibility Criteria
Inclusion
- Patients older than 18 years undergoing a PCI procedure
- Pretreatment with 600mg clopidogrel at least 2 hours before the intervention
- Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Exclusion
- Recent ST-elevation myocardial infarction within the last 48 hours
- Acute coronary syndromes with positive biomarkers (Troponin T \> 0.03 μg/L or CK-MB \> ULN)
- Cardiogenic shock
- 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 unless an ACT is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
- Treatment with bivalirudin within 24 hours before enrollment
- 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, 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 :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
2505 Patients enrolled
Trial Details
Trial ID
NCT00735280
Start Date
August 1 2008
End Date
March 1 2011
Last Update
January 5 2012
Active Locations (3)
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1
Herz-Zentrum
Bad Krozingen, Germany, 79189
2
Deutsches Herzzentrum München
München, Germany, 81541
3
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675