Clinical InvestigationAcute Ischemic Heart DiseaseRandomized trial comparing 600- with 300-mg loading dose of clopidogrel in patients with non–ST elevation acute coronary syndrome undergoing percutaneous coronary intervention: Results of the Platelet Responsiveness to Aspirin and Clopidogrel and Troponin Increment after Coronary intervention in Acute coronary Lesions (PRACTICAL) Trial
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Methods
The Platelet Responsiveness to Aspirin and Clopidogrel and Troponin Increment after Coronary intervention in Acute coronary Lesions (PRACTICAL) Trial involved 10 Australian hospitals. The trial was approved by the ethics committee of each participating hospital, and all patients provided written informed consent.
Patients
There were 256 patients recruited between January 2004 and November 2005, of whom 124 patients were randomized to receive clopidogrel 300 mg and 132 received clopidogrel 600 mg. There were 140 (54.7%) patients treated with PCI, 34 (13.3%) patients who underwent CABG, and 82 (32.0%) patients treated with medical management.
Baseline characteristics
Baseline characteristics are summarized in Table I.
Most of the patients (81.6%) had an elevated troponin at presentation. Almost 40% were on aspirin before presentation, and
Discussion
In this study, a 600-mg LD of clopidogrel produced significantly greater inhibition of ADP-induced platelet aggregation than a 300-mg LD but did not prevent post-PCI myonecrosis or clinical ischemic outcomes in patients with NSTEACS undergoing an early invasive management strategy. There was no association between preprocedural platelet aggregation and post-PCI myonecrosis among PCI-treated patients, more than two thirds of whom received a GPIIb-IIIa inhibitor during the procedure. A 600-mg LD
Conclusion
In conclusion, our study data confirm a modest incremental antiplatelet effect of a 600-mg clopidogrel LD compared with 300-mg LD but provide no support for a clinical benefit in patients with NSTEACS managed with an early invasive strategy including a high rate (69%) of GPIIb-IIIa inhibitor use during PCI.
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Clinical Trial Registration Information: Australian Clinical Trials Registry (http://www.actr.org.au/) number ACTRN012605000581662.
This study was supported by an unrestricted educational grant from Sanofi-Aventis, Sydney, Australia.