Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome (ISAR-REACT-4)

May 7, 2012 updated by: Deutsches Herzzentrum Muenchen

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1721

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany, 79189
        • Herz-Zentrum Bad Krozingen
      • Bad Neustadt, Germany, 97616
        • Herz- und Gefaessklinik, Kardiologie
      • Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain
      • Berlin, Germany, 12157
        • Vivantes Auguste Viktoria Klinikum
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukoelln
      • Muenchen, Germany, 81675
        • Medizinische Klinik, Klinikum rechts der Isar
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Osnabrueck, Germany, 49074
        • Marienhospital Osnabrueck
  • Italy
      • Firenze, Italy, 50134
        • Ospedale Cageggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abciximab+UFH
Abciximab and unfractionated heparin as bolus given during PCI and abciximab-perfusion for 12 hours after PCI
Drug: Abciximab + UFH
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)
Other Names:
  • ReoPro
Drug: Heparin
i.v. bolus of 70 units/kg/body weight of unfractionated heparin
Other Names:
  • unfractionated heparin
Active Comparator: Bivalirudin
Bivalirudin given only during PCI
Drug: Bivalirudin
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)
Other Names:
  • Angiox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of death, large recurrent myocardial infarction (MI), urgent target vessel revascularization (TVR) or major bleeding
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Major bleedings
Time Frame: 30 days
30 days
Composite end point of death, any recurrent myocardial infarction or urgent TVR
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. A01106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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