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Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Completed
CT.gov ID
NCT00133003
Collaborator
Technische Universität München (Other)
2,022
Enrollment
5
Locations
2
Arms
34.1
Duration (Months)
404.4
Patients Per Site
11.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Although percutaneous coronary interventions (PCIs) are an established therapeutic approach in patients presenting with acute coronary syndrome (ACS), it is still unclear which the best antithrombotic therapy to be applied periprocedurally is. The EPISTENT trial has shown that adding abciximab (a glycoprotein [GP] IIb/IIIa receptor inhibitor) to the therapy with ticlopidine plus aspirin significantly reduces the incidence of ischemic complications (death, myocardial infarction or reinterventions) after coronary stent implantation. Ticlopidine also reduces procedural complications but has a delayed onset of action after coronary stenting and has been replaced by clopidogrel, which provides similar efficacy and is associated with fewer side effects. Experimental studies have shown that a 600 mg loading dose of clopidogrel is safe and acts rapidly leading to a maximal inhibition of platelet aggregation within 2 hours after administration. In the ISAR-REACT trial, a 600 mg loading dose of clopidogrel was well tolerated, and associated with such a low frequency of early complications that the use of abciximab offered no clinically measurable benefit at 30 days. Although patients with ACS have frequently been treated with a "cooling-off" strategy for >48 hours before undergoing PCI, the ISAR-COOL trial demonstrated that patients undergoing PCI within 6-12 hours of presentation with an ACS actually suffer a lower rate of ischemic complications than those for whom an invasive approach is delayed. However, patients with ACS represent a higher risk subset and may need a more potent antithrombotic regimen periprocedurally. Therefore, the results of ISAR REACT, which was performed in low and intermediate risk patients, should not be generalized to high risk patients.

Comparison:

All patients with non-ST-segment elevation acute coronary syndromes who will undergo coronary angiography willing to participate in the trial will receive a loading dose of 600 mg clopidogrel at least 2 hours prior to the procedure. Eligible patients who do not meet the exclusion criteria in whom angiography reveals that PCI is planned will be randomized to receive either abciximab plus low-dose heparin, 70 units/kg, or high dose heparin (140 units/kg) plus placebo.

Study Design

Study Type:
Interventional
Actual Enrollment :
2022 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Glycoprotein IIb/IIIa Inhibition With Abciximab in Patients With ACS Undergoing Coronary Stenting After Pretreatment With a High Loading Dose of Clopidogrel (ISAR-REACT-2)
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Drug: Abciximab
0.25 mg/kg of body weight bolus, followed by a 0.125-microg/kg per minute [maximum, 10 microg/min] infusion for 12 hours, plus heparin, 70 U/kg of body weight
Other Names:
  • ReoPro

    		•
    Placebo Comparator: 2

    Drug: Placebo
    Placebo consist of placebo bolus and infusion of 12 hours (NaCl 0.9%), plus heparin bolus, 140 U/kg of body weight

    Outcome Measures

    Primary Outcome Measures

    1. Composite rate of death, myocardial infarction, and urgent target vessel revascularization within 30 days [30 days]

    Secondary Outcome Measures

    1. Major and minor bleeding complications in-hospital [in hospital]

    2. Death or myocardial infarction by 12 months [12 months]

    3. Target vessel revascularization by 12 months [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with acute coronary syndromes

    • Pretreatment (2 hours) with high loading dose (600 mg) clopidogrel

    • Significant angiographic lesions amenable to and requiring a PCI

    • Written informed consent

    Exclusion Criteria:

    • ST-segment elevation acute myocardial infarction within 48 hours from symptom onset

    • Hemodynamic instability

    • Pericarditis

    • Malignancies with life expectancy less than one year

    • Increased risk of bleeding

    • Oral anticoagulation therapy with coumarin derivative within 7 days

    • Recent use of GPIIb/IIIa inhibitors within 14 days

    • Severe uncontrolled hypertension >180 mmHg unresponsive to therapy

    • Relevant hematologic deviations: hemoglobin < 100g/L or hematocrit < 34%; platelet count < 100 x 109/L or platelet count > 600 x 109/L.

    • Known allergy to the study medication

    • Pregnancy (present or suspected)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Dante Pazzanese de Cardiologia São Paulo Brazil 500-04012180
    2 Herz-Zentrum Bad Krozingen Germany 79189
    3 Deutsches Herzzentrum Muenchen Munich Germany 80636
    4 First Medizinische Klinik, Klinikum rechts der Isar Munich Germany 81675
    5 St. Antonius Ziekenhuis Hospital Nieuwegein Netherlands 3435

    Sponsors and Collaborators

    • Deutsches Herzzentrum Muenchen
    • Technische Universität München

    Investigators

    • Study Chair: Albert Schomig, MD, Deutsches Herzzentrum Muenchen
    • Principal Investigator: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
    • Study Director: Peter B Berger, MD, Duke Clinical Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00133003
    Other Study ID Numbers:
    • GE IDE No. A00500
    First Posted:
    Aug 22, 2005
    Last Update Posted:
    Apr 15, 2008
    Last Verified:
    Apr 1, 2008
    Additional relevant MeSH terms:
    Coronary Disease
    Angina, Unstable
    Abciximab

    Study Results

    No Results Posted as of Apr 15, 2008