Back to resultsRandomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome (ISAR-REACT-4)
Primary Purpose
Myocardial Infarction, Coronary Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Abciximab + UFH
Bivalirudin
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring NSTEMI
Eligibility Criteria
Inclusion Criteria:
- Episode of unstable angina
- Elevated cardiac markers
- Angiographic lesions requiring PCI
- Informed, written consent
Exclusion Criteria:
- Age < 18 years and > 80 years
- ST-segment elevation acute myocardial infarction within 48 hours
- Cardiogenic shock
- Pericarditis
- Malignancies or other comorbid conditions 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, 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
- Oral anticoagulation therapy with coumarin derivative within the last 7 days
- Recent use of GPIIb/IIIa inhibitors within 14 days
- Treatment with unfractionated heparin within 4 hours unless ACT > 150sec; or low-molecular weight heparin within 8 hours before randomization
- Treatment with bivalirudin within 24 hours before randomization
- Severe uncontrolled hypertension > 180/110 mm Hg unresponsive to therapy
- Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days
- Relevant hematologic deviations
- Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis
- Known allergy or intolerance to the study medications, stainless steel or true anaphylaxis after prior exposure to contrast media
- Previous enrollment in this trial
- 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
- Patient's inability to fully cooperate with the study protocol
Sites / Locations
- Herz-Zentrum Bad Krozingen
- Herz- und Gefaessklinik, Kardiologie
- Vivantes Klinikum im Friedrichshain
- Vivantes Auguste Viktoria Klinikum
- Vivantes Klinikum Neukoelln
- Medizinische Klinik, Klinikum rechts der Isar
- Deutsches Herzzentrum Muenchen
- Marienhospital Osnabrueck
- Ospedale Cageggi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Abciximab+UFH
Bivalirudin
Arm Description
Abciximab and unfractionated heparin as bolus given during PCI and abciximab-perfusion for 12 hours after PCI
Bivalirudin given only during PCI
Outcomes
Primary Outcome Measures
Composite of death, large recurrent myocardial infarction (MI), urgent target vessel revascularization (TVR) or major bleeding
Secondary Outcome Measures
Composite end point of death, any recurrent myocardial infarction or urgent TVR
Major bleedings
Full Information
NCT ID
NCT00373451
First Posted
September 7, 2006
Last Updated
May 7, 2012
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT00373451
Brief Title
Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome
Acronym
ISAR-REACT-4
Official Title
Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Abciximab And Bivalirudin in Patients With Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Interventions (ISAR-REACT-4)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which of these anti-clotting medications, abciximab plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and bleeding complications in patients suffering from a heart attack and undergoing coronary intervention.
Detailed Description
Non-ST elevation myocardial infarction (NSTEMI) is associated with an increased risk of death and is a major reason for hospital admissions. Most frequently, the sequence of events that leads to NSTEMI is characterized by a disrupted atherosclerotic plaque, platelet activation and aggregation, thrombus formation and microembolizations. Patients with NSTEMI are treated with an early invasive strategy and there is intensive work in progress to define the optimal antithrombotic therapy to be used in adjunct to percutaneous coronary intervention (PCI) in these patients. Bivalirudin, a direct thrombin inhibitor, and the glycoprotein IIb/IIIa inhibitor (GPI) abciximab have been in the focus of recent trials in patients with acute coronary syndrome (ACS). In a recent randomized, open-label trial (ACUITY trial), patients with the suspicion of ACS on the basis of the type of anginal symptoms, ST-segment displacement, elevated biomarkers or several risk indicators were randomized to receive bivalirudin alone with bail-out GPIs, bivalirudin plus GPIs, or heparin/low-molecular weight heparin plus a GPI. The GPIs most frequently used were eptifibatide and tirofiban. Abciximab was given in only < 9% of the cases. In another randomized, double-blind, placebo-controlled trial (ISAR-REACT-2) including ACS patients undergoing PCI, abciximab was administered in cath lab and was associated with a significant reduction of ischemic events in patients with NSTEMI, and did not lead to a measurable increase in major bleeding complications. However, it is not known whether abciximab is also superior to bivalirudin in patients with NSTEMI. We designed this study to assess whether abciximab added to unfractionated heparin is superior to bivalirudin in patients with NSTEMI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Disease
Keywords
NSTEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1721 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abciximab+UFH
Arm Type
Experimental
Arm Description
Abciximab and unfractionated heparin as bolus given during PCI and abciximab-perfusion for 12 hours after PCI
Arm Title
Bivalirudin
Arm Type
Active Comparator
Arm Description
Bivalirudin given only during PCI
Intervention Type
Drug
Intervention Name(s)
Abciximab + UFH
Other Intervention Name(s)
ReoPro
Intervention Description
Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute [maximum of 10 µg/minute] infusion for 12 hours)
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Angiox
Intervention Description
Bivalirudin (intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure)
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
unfractionated heparin
Intervention Description
i.v. bolus of 70 units/kg/body weight of unfractionated heparin
Primary Outcome Measure Information:
Title
Composite of death, large recurrent myocardial infarction (MI), urgent target vessel revascularization (TVR) or major bleeding
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Composite end point of death, any recurrent myocardial infarction or urgent TVR
Time Frame
30 days
Title
Major bleedings
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Episode of unstable angina
Elevated cardiac markers
Angiographic lesions requiring PCI
Informed, written consent
Exclusion Criteria:
Age < 18 years and > 80 years
ST-segment elevation acute myocardial infarction within 48 hours
Cardiogenic shock
Pericarditis
Malignancies or other comorbid conditions 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, 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
Oral anticoagulation therapy with coumarin derivative within the last 7 days
Recent use of GPIIb/IIIa inhibitors within 14 days
Treatment with unfractionated heparin within 4 hours unless ACT > 150sec; or low-molecular weight heparin within 8 hours before randomization
Treatment with bivalirudin within 24 hours before randomization
Severe uncontrolled hypertension > 180/110 mm Hg unresponsive to therapy
Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days
Relevant hematologic deviations
Glomerular filtration rate (GFR) < 30 ml/min or serum creatinine > 30 mg/L or dependence on renal dialysis
Known allergy or intolerance to the study medications, stainless steel or true anaphylaxis after prior exposure to contrast media
Previous enrollment in this trial
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
Patient's inability to fully cooperate with the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Schoemig, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz-Zentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Herz- und Gefaessklinik, Kardiologie
City
Bad Neustadt
ZIP/Postal Code
97616
Country
Germany
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Vivantes Auguste Viktoria Klinikum
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Vivantes Klinikum Neukoelln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Medizinische Klinik, Klinikum rechts der Isar
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Marienhospital Osnabrueck
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Ospedale Cageggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
12. IPD Sharing Statement
Citations:
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Results Reference
background
PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Learn more about this trial
Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome
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