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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00133003
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : April 15, 2008
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date  ICMJE August 18, 2005
First Posted Date  ICMJE August 22, 2005
Last Update Posted Date April 15, 2008
Study Start Date  ICMJE March 2003
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
Composite rate of death, myocardial infarction, and urgent target vessel revascularization within 30 days [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2005)
Composite rate of death, myocardial infarction, and urgent target vessel revascularization within 30 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
  • Major and minor bleeding complications in-hospital [ Time Frame: in hospital ]
  • Death or myocardial infarction by 12 months [ Time Frame: 12 months ]
  • Target vessel revascularization by 12 months [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2005)
  • Major and minor bleeding complications in-hospital
  • Death or myocardial infarction by 12 months
  • Target vessel revascularization by 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Disease
  • Angina, Unstable
Intervention  ICMJE
  • 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 Name: ReoPro
  • Drug: Placebo
    Placebo consist of placebo bolus and infusion of 12 hours (NaCl 0.9%), plus heparin bolus, 140 U/kg of body weight
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Abciximab
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2007)
2022
Original Enrollment  ICMJE
 (submitted: August 18, 2005)
1800
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 10^9/L or platelet count > 600 x 10^9/L.
  • Known allergy to the study medication
  • Pregnancy (present or suspected)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00133003
Other Study ID Numbers  ICMJE GE IDE No. A00500
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deutsches Herzzentrum Muenchen
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE Technische Universität München
Investigators  ICMJE
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
PRS Account Deutsches Herzzentrum Muenchen
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP