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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003013-32-DE

Enrollment

4500

Registered

2005-09-21

Start date

2005-11-08

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease MedDRA version: 8.1 Level: LLT Classification code 10011099 Term: Coronary disease

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 Other descriptive name: Angiox,

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 mg/L or dependence on renal dialysis. Known allergy to the study medications unfractionated heparin, bivalirudin Pregnancy (present, suspected or planned).

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026