PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED; MULTICENTER TRIAL OF BIVALIRUDIN AND UN-FRACTIONATED HEPARIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS - ISAR-REACT-3

Conditions: Coronary Artery Disease
MedDRA version: 8.1Level: LLTClassification code 10011099Term: Coronary disease

Registration Number: EUCTR2005-003013-32-DE

Lead Sponsor: Deutsches Herzzentrum München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4500

Inclusion Criteria

Patients older than age 18
Pretreatment with clopidogrel at least 2 hours before percutaneous coronary intervention according to the percutaneous coronary intervention guidelines
Informed, written consent
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

Recent ST-elevation myocardial infarction within the last 48 hours.
Cardiogenic shock.
Acute coronary syndromes with positive biomarkers (Troponin T > 0.03 µg/L or CK-MB > ULN)
Malignancies or other comorbid conditions with life expectancy less than one year
Active bleeding; bleeding diathesis
Oral anticoagulation therapy with coumarin derivative within the last 7 days
Treatment with unfractionated heparin within 6 hours or low-molecular weight heparin within 8 hours before randomization.
Treatment with bivalirudin within 24 hours before randomization
Glomerular filtration rate < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis.
Known allergy to the study medications unfractionated heparin, bivalirudin
Pregnancy (present, suspected or planned).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of bivalirudin therapy to reduce the risk of thrombotic and bleeding complications in patients undergoing percutaneous coronary intervention as compared with unfractionated heparin therapy. ;Secondary Objective: Composite rate of death, myocardial infarction or urgent target vessel revascularization within 30 days after the index percutaneous coronary intervention <br>Composite rate of death, myocardial infarction or target vessel revascularization at 1 year after the index percutaneous coronary intervention ;Primary end point(s): Cumulative incidence of death, myocardial infarction, or urgent target vessel revascularization owing to myocardial ischemia during one month after percutaneous coronary intervention

Secondary Outcome Measures