Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639]

Gašparović, Hrvoje and Petričević, Mate and Kopjar, Tomislav and Đurić, Željko and Svetina, Lucija and Biočina, Bojan (2012) Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639]. Trials, 13 (148). ISSN 1745-6215

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BACKGROUND: Coronary artery disease remains the dominant cause of mortality in developed countries. While platelets have been recognized to play a pivotal role in atherothrombosis, the ideal antiplatelet regime after coronary artery surgery remains elusive. The evolution of CABG has presently moved beyond technical improvements to involve modulation of pharmacologic management designed to improve patient outcomes. The aim of this trial will be to test the hypothesis that the addition of clopidogrel to patients with documented postoperative aspirin resistance will reduce the incidence of major cardiovascular events. ----- METHODS: Patients scheduled for isolated coronary artery surgery will be eligible for the study. Patients in whom postoperative multiple electrode aggregometry documents aspirin resistance will be randomized into two groups. The control group will receive 300 mg of aspirin. The dual antiplatelet group will receive 75 mg of clopidogrel in addition to 300 mg of aspirin. Patients will be followed for 6 months. Major adverse cardiac and cerebrovascular events (death from any cause, myocardial infarction, stroke, hospitalization due to cardiovascular pathology) as well as bleeding events will be recorded. ----- DISCUSSION: This will be the first trial that will specifically address the issue of dual antiplatelet therapy in patients undergoing coronary artery surgery who have been found to be aspirin resistant. In the event that the addition of clopidogrel proves to be beneficial in this subset of surgical patients, this study could significantly impact their future antiplatelet management. This randomized controlled trial has been registered at the ClinicalTrials.gov website (Identifier NCT01159639).

Item Type: Article
MeSH: Aspirin / adverse effects ; Aspirin / therapeutic use ; Cardiovascular Diseases / etiology ; Cardiovascular Diseases / mortality ; Cardiovascular Diseases / therapy ; Clopidogrel ; Coronary Artery Bypass / adverse effects ; Coronary Artery Bypass / mortality ; Croatia ; Drug Resistance ; Drug Therapy, Combination ; Hemorrhage / chemically induced ; Humans ; Patient Readmission ; Platelet Aggregation / drug effects ; Platelet Aggregation Inhibitors / adverse effects ; Platelet Aggregation Inhibitors / therapeutic use ; Platelet Function Tests ; Research Design ; Ticlopidine / adverse effects ; Ticlopidine / analogs & derivatives ; Ticlopidine / therapeutic use ; Time Factors ; Treatment Outcome
Departments: Katedra za kirurgiju
Depositing User: Marijan Šember
Status: Published
Gašparović, HrvojeUNSPECIFIED
Petričević, MateUNSPECIFIED
Kopjar, TomislavUNSPECIFIED
Svetina, LucijaUNSPECIFIED
Date: 25 August 2012
Date Deposited: 07 Feb 2013 09:51
Last Modified: 08 Jul 2020 11:04
Subjects: /
Related URLs:
URI: http://medlib.mef.hr/id/eprint/1817

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