American heart journal
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American heart journal · Sep 2009
Randomized Controlled Trial Multicenter StudyThe Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.
The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features.
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American heart journal · Sep 2009
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialDetection of myocardial injury in patients with unstable angina using a novel nanoparticle cardiac troponin I assay: observations from the PROTECT-TIMI 30 Trial.
At least 30% of patients with non-ST-elevation acute coronary syndrome present without evidence of myonecrosis using current generation troponin assays. A new generation of research assays for troponin that offer a >10-fold increase in analytical sensitivity has emerged. ⋯ In this pilot study using a nanoparticle assay for cTnI, myocardial injury was detectable in a substantial proportion of patients presently classified as having unstable angina, suggesting that ischemia with rest pain without injury is rare. The emergence of a new generation of troponin assays has the potential to lead to new clinical applications based on enhanced analytical performance at very low concentrations of troponin.
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American heart journal · Sep 2009
Randomized Controlled Trial Comparative StudyEffect of prasugrel versus clopidogrel on outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention without stent implantation: a TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel (TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38 substudy.
Prasugrel led to a significant reduction in ischemic cardiovascular events among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with stent implantation compared to clopidogrel. Whether this benefit extends to patients undergoing PCI without stent implantation is unknown. ⋯ Among ACS patients who underwent PCI without stent implantation, prasugrel therapy tended to reduce clinical ischemic events and to increase bleeding events to a similar magnitude as among patients who received stents.
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American heart journal · Jul 2009
Randomized Controlled Trial Comparative StudyBone marrow mobilization with granulocyte macrophage colony-stimulating factor improves endothelial dysfunction and exercise capacity in patients with peripheral arterial disease.
We hypothesized that granulocyte macrophage colony-stimulating factor (GM-CSF) administration will be safe and will improve endothelial dysfunction and exercise capacity by mobilizing progenitor cells in patients with peripheral arterial disease (PAD). ⋯ Granulocyte macrophage colony-stimulating factor therapy in patients with PAD was associated with mobilization of progenitor cells, improvement of endothelial dysfunction, and exercise capacity. The efficacy of strategies designed to mobilize bone marrow progenitors warrants further study in patients with PAD.
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American heart journal · May 2009
Randomized Controlled Trial Multicenter Study Comparative StudyEvaluation of individualized clopidogrel therapy after drug-eluting stent implantation in patients with high residual platelet reactivity: design and rationale of the GRAVITAS trial.
The inhibitory response to clopidogrel varies widely among individuals. Data suggest that patients with high residual platelet reactivity despite clopidogrel therapy are at greater risk for thrombotic events after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The Gauging Responsiveness with A VerifyNow assay--Impact on Thrombosis And Safety (GRAVITAS) trial is designed to evaluate whether tailored clopidogrel therapy using a point-of-care platelet function assay reduces major adverse cardiovascular events after DES implantation. ⋯ GRAVITAS is the first large-scale clinical trial designed to examine whether adjustment of clopidogrel therapy on the basis of platelet function testing using a point-of-care assay safely improves outcomes after PCI with DES.