Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. Identifier: NCT00133003
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : April 15, 2008
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen

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
Coronary Disease Angina, Unstable Drug: Abciximab Drug: Placebo 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 Ticlopidine also reduces procedural complications but has a delayed onset of action after coronary stenting and has been replaced by clopidogrel, which provides similar efficacy and is associated with fewer side effects.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.


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Abciximab

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 Name: 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

Primary Outcome Measures :
  1. Composite rate of death, myocardial infarction, and urgent target vessel revascularization within 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Major and minor bleeding complications in-hospital [ Time Frame: in hospital ]
  2. Death or myocardial infarction by 12 months [ Time Frame: 12 months ]
  3. Target vessel revascularization by 12 months [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 10^9/L or platelet count > 600 x 10^9/L.
  • Known allergy to the study medication
  • Pregnancy (present or suspected)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133003

Layout table for location information
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 500-04012180
Bad Krozingen, Germany, 79189
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
St. Antonius Ziekenhuis Hospital
Nieuwegein, Netherlands, 3435
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Technische Universität München
Layout table for investigator information
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
Publications of Results:
Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT00133003    
Other Study ID Numbers: GE IDE No. A00500
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Disease
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Platelet Aggregation Inhibitors