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Randomized evaluation of ticagrelor monotherapy after 3-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with new-generation sirolimus-eluting stents: TICO trial rationale and design
ConclusionsThe TICO trial is an ongoing trial evaluating the efficacy and safety of ticagrelor monotherapy following 3-month DAPT exclusively in ACS patients treated with uniform BP-SES. It may provide novel insights regarding the need for adjusted use of DAPT for rebalancing risk–benefit in current practice and changing from the conventional concept of aspirin maintenance to a ticagrelor-based regimen in the management of ACS.
Source: American Heart Journal - March 9, 2019 Category: Cardiology Source Type: research

Relationship of stroke and bleeding risk profiles to efficacy and safety of dabigatran dual therapy versus warfarin triple therapy in atrial fibrillation after PCI: An ancillary analysis from the RE-DUAL PCI trial
ConclusionDabigatran dual therapy reduced bleeding events irrespective of bleeding risk category and demonstrated similar efficacy regardless of stroke risk category when compared with warfarin triple therapy.
Source: American Heart Journal - March 4, 2019 Category: Cardiology Source Type: research

Evaluation of the Safety and Efficacy of an Edoxaban-based Antithrombotic Regimen in Patients with Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) with Stent Placement: Rationale and Design of the ENTRUST-AF PCI Trial
Publication date: Available online 23 October 2017 Source:American Heart Journal Author(s): Pascal Vranckx, Thorsten Lewalter, Marco Valgimigli, Jan G. Tijssen, Paul-Egbert Reimitz, Lars Eckardt, Hans-Joachim Lanz, Wolfgang Zierhut, Rüdiger Smolnik, Andreas Goette Background The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was non-inferior to a vitamin-K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rate...
Source: American Heart Journal - October 23, 2017 Category: Cardiology Source Type: research

Cangrelor reduces the risk of ischemic complications in patients with single-vessel and multi-vessel disease undergoing percutaneous coronary intervention: Insights from the CHAMPION PHOENIX trial
Conclusion In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. Clinical perspectives What's known? Cangrelor is a novel, intravenous, potent, and rapidly acting P2Y12 inhibitor that has been demonstrated to reduce the rate of ischemic events at 48hours in patients who received PCI compared with clopidogrel. What's new? In contrast to prior studies, we found that in this modern cohort, patients with SVD and MVD had a similar risk of i...
Source: American Heart Journal - April 18, 2017 Category: Cardiology Source Type: research

Cangrelor reduces the risk of ischemic complications in patients with single and multi-vessel disease undergoing PCI: insights from the CHAMPION PHOENIX Trial
Conclusion In the CHAMPION-PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. Clinical Perspectives. What's known? Cangrelor is a novel, intravenous, potent, and rapidly-acting P2Y12 inhibitor, that has been demonstrated to reduce the rate of ischemic events at 48hours in patients who received PCI compared with clopidogrel. What's new? In contrast to prior studies, we found that in this modern cohort, patients with SVD and MVD had a similar risk of...
Source: American Heart Journal - March 9, 2017 Category: Cardiology Source Type: research

A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial
Conclusions The HOST-EXAM will be the first large-scale randomized controlled study to directly compare the efficacy and safety of long-term antiplatelet monotherapy beyond DAPT after DES implantation. This study will provide clinical evidence to establish optimal regimen for long-term antiplatelet therapy after DES implantation.
Source: American Heart Journal - December 20, 2016 Category: Cardiology Source Type: research

A randomized clinical trial comparing long-term clopidogrel versus aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the HOST-EXAM trial
Conclusions The HOST-EXAM will be the first large-scale randomized controlled study to directly compare the efficacy and safety of long-term antiplatelet monotherapy beyond DAPT after DES implantation. This study will provide clinical evidence to establish optimal regimen for long-term antiplatelet therapy after DES implantation.
Source: American Heart Journal - December 9, 2016 Category: Cardiology Source Type: research

Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study
Conclusions GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy–based strategy in subjects without need of chronic oral anticoagulation.
Source: American Heart Journal - November 25, 2016 Category: Cardiology Source Type: research

Trial design: Rivaroxaban for the prevention of major cardiovascular events post transcatheter aortic valve replacement: rationale and design of the GALILEO study
Conclusions GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.
Source: American Heart Journal - October 31, 2016 Category: Cardiology Source Type: research

Impact of glycoprotein IIb/IIIa inhibitors on the efficacy and safety of ticagrelor compared with clopidogrel in patients with acute coronary syndromes: Analysis from the Platelet Inhibition and Patient Outcomes (PLATO) Trial
Conclusions In patients with acute coronary syndrome undergoing early PCI, the efficacy and safety of ticagrelor as compared with clopidogrel were not modified by GPI use according to the primary efficacy and safety end point of the trial, although there were indications of greater benefit on definite stent thrombosis and more major or minor bleeding with ticagrelor in patients without (vs with) GPI treatment.
Source: American Heart Journal - May 7, 2016 Category: Cardiology Source Type: research

Impact of Glycoprotein IIb/IIIa Inhibitors on the Efficacy and Safety of Ticagrelor Compared to Clopidogrel in Patients with Acute Coronary Syndromes - Analysis from the PLATO (Platelet Inhibition and Patient Outcomes) Trial
Conclusions In patients with ACS undergoing early PCI the efficacy and safety of ticagrelor as compared with clopidogrel was not modified by GPI use according to the primary efficacy and safety endpoint of the trial, although there were indications of greater benefit on definite stent thrombosis and more major or minor bleeding with ticagrelor in patients without (vs. with) GPI treatment.
Source: American Heart Journal - April 13, 2016 Category: Cardiology Source Type: research

A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study
Publication date: April 2016 Source:American Heart Journal, Volume 174 Author(s): Thomas J. Povsic, Matthew T. Roe, Erik Magnus Ohman, Philippe Gabriel Steg, Stefan James, Alexei Plotnikov, Hardi Mundl, Robert Welsh, Christoph Bode, Charles Michael Gibson Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to ...
Source: American Heart Journal - February 23, 2016 Category: Cardiology Source Type: research

A Randomized Trial to Compare the Safety of Rivaroxaban versus Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome: The Design of the GEMINI-ACS-1 Phase II Study
Publication date: Available online 18 January 2016 Source:American Heart Journal Author(s): Thomas J. Povsic, Matthew T. Roe, E. Magnus Ohman, Philippe Gabriel Steg, Stefan James, Alexei Plotnikov, Hardi Mundl, Robert Welsh, Christoph Bode, C. Michael Gibson Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown ...
Source: American Heart Journal - January 19, 2016 Category: Cardiology Source Type: research

CYP2C19 genotype–guided antiplatelet therapy in ST-segment elevation myocardial infarction patients—Rationale and design of the Patient Outcome after primary PCI (POPular) Genetics study
Conclusion: The POPular Genetics study is the first large-scale trial comparing CYP2C19 genotype–guided antiplatelet therapy to a nontailored strategy in terms of net clinical benefit, safety, and cost-effectiveness.
Source: American Heart Journal - March 24, 2014 Category: Cardiology Authors: Thomas O. Bergmeijer, Paul W.A. Janssen, Jurjan C. Schipper, Khalid Qaderdan, Maycel Ishak, Rianne S. Ruitenbeek, Folkert W. Asselbergs, Arnoud W.J. van ‘t Hof, Willem J.M. Dewilde, Fabrizio Spanó, Jean-Paul R. Herrman, Johannes C. Kelder, Maarten J. P Tags: Trial Design Source Type: research

Rationale and design of The Intracoronary Stenting and Antithrombotic Regimen—Testing of a six-week versus a six-month clopidogrel treatment Regimen In Patients with concomitant aspirin and oraL anticoagulant therapy following drug-Eluting stenting (ISAR-TRIPLE) study
Background: An increasing number of patients undergoing coronary stenting need lifelong anticoagulation and therefore require a triple therapy typically consisting of aspirin, clopidogrel, and a vitamin K antagonist. Triple therapy confers an elevated bleeding risk as compared with dual therapy; however, omission of either antiplatelet or anticoagulation therapy might increase the risk of stent thrombosis or thrombembolic events. Although guidelines recommend a duration of dual antiplatelet therapy of 6 to 12months after drug-eluting stent (DES) implantation, the optimal duration of dual antiplatelet therapy in patients re...
Source: American Heart Journal - January 16, 2014 Category: Cardiology Authors: K. Anette Fiedler, Robert A. Byrne, Stefanie Schulz, Dirk Sibbing, Julinda Mehilli, Tareq Ibrahim, Michael Maeng, Karl-Ludwig Laugwitz, Adnan Kastrati, Nikolaus Sarafoff Tags: Trial Design Source Type: research