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

NCT00133003 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. A00500
• Study Type: interventional
• Target: 2,022
• Locations: 3 countries
• Sites: 5

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.

Conditions

Coronary Disease; Angina, Unstable

Outcome Measures

Primary Outcomes (1)

• Composite rate of death, myocardial infarction, and urgent target vessel revascularization within 30 days

  30 days

Secondary Outcomes (3)

• Major and minor bleeding complications in-hospital

  in hospital

• Death or myocardial infarction by 12 months

  12 months

• Target vessel revascularization by 12 months

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Abciximab

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Abciximab DRUG

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

Also known as: ReoPro

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Technical University of Munich: collaborator

Study Sites (5)

Instituto Dante Pazzanese de Cardiologia

São Paulo, 500-04012180, Brazil

Location

Herz-Zentrum

Bad Krozingen, 79189, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

First Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

St. Antonius Ziekenhuis Hospital

Nieuwegein, 3435, Netherlands

Location

Related Publications (8)

• Topol EJ, Mark DB, Lincoff AM, Cohen E, Burton J, Kleiman N, Talley D, Sapp S, Booth J, Cabot CF, Anderson KM, Califf RM. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1999 Dec 11;354(9195):2019-24. doi: 10.1016/s0140-6736(99)10018-7.

  PMID: 10636365 BACKGROUND

• Topol EJ, Moliterno DJ, Herrmann HC, Powers ER, Grines CL, Cohen DJ, Cohen EA, Bertrand M, Neumann FJ, Stone GW, DiBattiste PM, Demopoulos L; TARGET Investigators. Do Tirofiban and ReoPro Give Similar Efficacy Trial. Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization. N Engl J Med. 2001 Jun 21;344(25):1888-94. doi: 10.1056/NEJM200106213442502.

  PMID: 11419425 BACKGROUND

• Neumann FJ, Kastrati A, Pogatsa-Murray G, Mehilli J, Bollwein H, Bestehorn HP, Schmitt C, Seyfarth M, Dirschinger J, Schomig A. Evaluation of prolonged antithrombotic pretreatment ("cooling-off" strategy) before intervention in patients with unstable coronary syndromes: a randomized controlled trial. JAMA. 2003 Sep 24;290(12):1593-9. doi: 10.1001/jama.290.12.1593.

  PMID: 14506118 BACKGROUND

• Muller I, Seyfarth M, Rudiger S, Wolf B, Pogatsa-Murray G, Schomig A, Gawaz M. Effect of a high loading dose of clopidogrel on platelet function in patients undergoing coronary stent placement. Heart. 2001 Jan;85(1):92-3. doi: 10.1136/heart.85.1.92. No abstract available.

  PMID: 11119474 BACKGROUND

• Pache J, Kastrati A, Mehilli J, Gawaz M, Neumann FJ, Seyfarth M, Hall D, Braun S, Dirschinger J, Schomig A. Clopidogrel therapy in patients undergoing coronary stenting: value of a high-loading-dose regimen. Catheter Cardiovasc Interv. 2002 Apr;55(4):436-41. doi: 10.1002/ccd.10092.

  PMID: 11948888 BACKGROUND

• Kastrati A, Mehilli J, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Bollwein H, Volmer C, Gawaz M, Berger PB, Schomig A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med. 2004 Jan 15;350(3):232-8. doi: 10.1056/NEJMoa031859.

  PMID: 14724302 BACKGROUND

• Kastrati A, Mehilli J, Neumann FJ, Dotzer F, ten Berg J, Bollwein H, Graf I, Ibrahim M, Pache J, Seyfarth M, Schuhlen H, Dirschinger J, Berger PB, Schomig A; Intracoronary Stenting and Antithrombotic: Regimen Rapid Early Action for Coronary Treatment 2 (ISAR-REACT 2) Trial Investigators. Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial. JAMA. 2006 Apr 5;295(13):1531-8. doi: 10.1001/jama.295.13.joc60034. Epub 2006 Mar 13.

  PMID: 16533938 RESULT

• Ndrepepa G, Kastrati A, Mehilli J, Neumann FJ, ten Berg J, Bruskina O, Dotzer F, Seyfarth M, Pache J, Dirschinger J, Ulm K, Berger PB, Schomig A. Age-dependent effect of abciximab in patients with acute coronary syndromes treated with percutaneous coronary interventions. Circulation. 2006 Nov 7;114(19):2040-6. doi: 10.1161/CIRCULATIONAHA.106.642306. Epub 2006 Oct 23.

  PMID: 17060377 DERIVED

MeSH Terms

Conditions

Coronary Disease; Angina, Unstable

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Albert Schomig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Peter B Berger, MD

  Duke Clinical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: March 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: April 15, 2008

Record last verified: 2008-04

Locations

DE (3); BR (1); NL (1)