Acute Coronary Syndrome MedDRA version: 8.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Trade Name: Angiox
Product Name: Bivalirudin
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Bivalirudin
CAS Number: 128270-60-0
Concentration unit: mg milligra
Sponsors
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with an episode of angina (with an accelerating pattern or prolonged [>20minutes] or recurrent episodes at rest or with minimal effort) within the preceding 48 hours. 2.Elevated cardiac markers above the upper normal limit (Troponin or CK-MB) 3.Angiographic lesions requiring PCI. 4.Informed, written consent by the patient or her/his legally-authorized representative for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Age =18 years and >80 years. 2.ST-segment elevation acute myocardial infarction (ST-segment =0.1 mV elevation in =2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset. 3.Cardiogenic shock. 4.Pericarditis 5.Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance. 6.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. 7.Oral anticoagulation therapy with coumarin derivative within the last 7 days. 8.Recent use of GPIIb/IIIa inhibitors within 14 days. 9.Treatment with unfractionated heparin within 4 hours unless an ACT is less than 150 or low-molecular weight heparin within 8 hours before randomization. 10.Treatment with bivalirudin within 24 hours before randomization. 11.Severe uncontrolled hypertension >180/110 mmHg unresponsive to therapy 12.Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days. 13.Relevant hematologic deviations: hemoglobin 600 x 109 cells/L. 14.Glomerular filtration rate (GFR) 30 mg/L or dependence on renal dialysis. 15.Known allergy or intolerance to the study medications: aspirin, abciximab, clopidogrel, UFH, bivalirudin; stainless steel; true anaphylaxis after prior exposure to contrast media. 16.Previous enrollment in this trial. 17.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. 18.Patient’s inability to fully cooperate with the study protocol. 19.Other contraindication according to the summary of product characteristics of ReoPro®, Angiox® or Heparin-Natrium®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of abciximab plus unfractionated heparin compared to bivalirudin in patients with NSTEMI undergoing PCI.;Secondary Objective: Efficacy: the 30-day composite rate of death, any recurrent MI or urgent TVR. The diagnosis of any myocardial infarction requires the presence of new significant Q-waves in 2 or more contiguous electrographic leads or creatine kinase (CK)/CK-MB elevation >3 times the upper limit of normal. Safety: the 30-day major bleeding rate. ;Primary end point(s): The primary outcome measure will be the composite end point of death, large recurrent MI, urgent TVR or major bleeding within 30 days from randomization. | — |
Countries
Germany
Outcome results
None listed