Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy
NCT ID: NCT01572129
Last Updated: 2012-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2011-11-30
Brief Summary
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The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Reload
600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg
Clopidogrel
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
Placebo
Placebo arm in addition to the chronic daily dose of 75 mg
Placebo
Placebo in addition to the chronic daily dose of 75 mg
Interventions
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Clopidogrel
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
Placebo
Placebo in addition to the chronic daily dose of 75 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography
Exclusion Criteria
* platelet count \< 70 × 10\^9/L
* high bleeding risk
* coronary bypass grafting in the previous 3 months
18 Years
90 Years
ALL
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Patti Giuseppe
MD, FACC, Co-Chair of the ARMYDA Study Group, Assistant Professor of Cardiology
Principal Investigators
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Giuseppe Patti, MD
Role: PRINCIPAL_INVESTIGATOR
Campus Bio-Medico University
Locations
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Vito Fazzi Hospital
Lecce, Lecce, Italy
Campus Bio-Medico University
Rome, Rome, Italy
Countries
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Central Contacts
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References
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Di Sciascio G, Patti G, Pasceri V, Colonna G, Mangiacapra F, Montinaro A; ARMYDA-4 RELOAD Investigators. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43. doi: 10.1093/eurheartj/ehq081. Epub 2010 Apr 2.
Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19.
Other Identifiers
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2011-005449-11
Identifier Type: -
Identifier Source: org_study_id
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