Acute Coronary Syndrome | Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy
Acute Coronary Syndrome research study
What is the primary objective of this study?
Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention. 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.
Who is eligible to participate?
Inclusion Criteria: - chronic (> 10 days) therapy with clopidogrel (75 mg/day) - non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography Exclusion Criteria: - primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction - platelet count < 70 × 10^9/L - high bleeding risk - coronary bypass grafting in the previous 3 months
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Coronary Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Clopidogrel600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
Drug:PlaceboPlacebo in addition to the chronic daily dose of 75 mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Reload600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg
PlaceboPlacebo arm in addition to the chronic daily dose of 75 mg
Start Date: November 2011
Phase: Phase 4
Primary Outcome: Major Adverse Cardiovascular Events
Secondary Outcome: Bleeding Events
Study sponsors, principal investigator, and references
Principal Investigator: Giuseppe Patti, MD
Lead Sponsor: Campus Bio-Medico University
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.