Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Deutsches Herzzentrum Muenchen Technische Universität München |
---|---|
Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00133003 |
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 | Intervention | Phase |
---|---|---|
Coronary Disease Angina, Unstable |
Drug: Abciximab Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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) |
Enrollment: | 2022 |
Study Start Date: | March 2003 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
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
|
2: Placebo Comparator |
Drug: Placebo
Placebo consist of placebo bolus and infusion of 12 hours (NaCl 0.9%), plus heparin bolus, 140 U/kg of body weight
|
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 Ticlopidine also reduces procedural complications but has a delayed onset of action after coronary stenting and has been replaced by clopidogrel, which provides similar efficacy and is associated with fewer side effects.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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Instituto Dante Pazzanese de Cardiologia | |
São Paulo, Brazil, 500-04012180 | |
Germany | |
Deutsches Herzzentrum Muenchen | |
Munich, Germany, 80636 | |
First Medizinische Klinik, Klinikum rechts der Isar | |
Munich, Germany, 81675 | |
Herz-Zentrum | |
Bad Krozingen, Germany, 79189 | |
Netherlands | |
St. Antonius Ziekenhuis Hospital | |
Nieuwegein, Netherlands, 3435 |
Study Chair: | Albert Schomig, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
Study Director: | Peter B Berger, MD | Duke University |
Responsible Party: | Deutsches Herzzentrum Muenchen ( Deutsches Herzzentrum Muenchen ) |
Study ID Numbers: | GE IDE No. A00500 |
Study First Received: | August 18, 2005 |
Last Updated: | April 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00133003 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Arterial Occlusive Diseases Anticoagulants Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Abciximab Pain Ischemia Arteriosclerosis Calcium heparin |
Chest Pain Coronary Disease Signs and Symptoms Clopidogrel Acute Coronary Syndrome Platelet Aggregation Inhibitors Heparin PS-K Angina, Unstable Coronary Artery Disease |
Arterial Occlusive Diseases Anticoagulants Heart Diseases Myocardial Ischemia Hematologic Agents Angina Pectoris Vascular Diseases Abciximab Pain Arteriosclerosis Pharmacologic Actions |
Chest Pain Coronary Disease Signs and Symptoms Therapeutic Uses Clopidogrel Acute Coronary Syndrome Platelet Aggregation Inhibitors Cardiovascular Diseases Angina, Unstable Coronary Artery Disease |