A Randomised, Open, Parallel-group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination With Clopidogrel and Aspirin in Patients Undergoing Elective Percutaneous Coronary Intervention in Comparison With Unfractionated Heparin, Clopidogrel and Aspirin
Sponsor study identifier
interventional
140
2 countries
8
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2006
Actual (reported)This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
October 2006
Actual (reported)July 26, 2007
Actual (reported)July 30, 2007
Actual (reported)December 5, 2012
Actual (reported)Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
5 - 10 min after initial bolus
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30 Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay
30 Days
Aalst, Belgium
Bad Nauheim, Germany
Cologne, Germany
Dachau, Germany
Düren, Germany
Frankfurt, Germany
Halle, Germany
Mainz, Germany
Rossig L, Genth-Zotz S, Rau M, Heyndrickx GR, Schneider T, Gulba DC, Desaga M, Buerke M, Harder S, Zeiher AM; ARG-E04 study group. Argatroban for elective percutaneous coronary intervention: the ARG-E04 multi-center study. Int J Cardiol. 2011 Apr 14;148(2):214-9. doi: 10.1016/j.ijcard.2010.02.044. Epub 2010 Mar 11.
Professor
Information at Mitsubishi Pharma Europe
140 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2007
First Posted
July 30, 2007
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Study Completion
October 2006
Actual (reported)Last Updated
January 6, 2026
Results First Posted
December 5, 2012
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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