American heart journal
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American heart journal · Jun 2019
Randomized Controlled Trial Multicenter StudyRandomized 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.
Ticagrelor monotherapy after short-term dual-antiplatelet therapy (DAPT) may optimize ischemic and bleeding risks, particularly for acute coronary syndrome (ACS) patients, because its strategy is less potent than ticagrelor-based DAPT but more potent than aspirin or clopidogrel monotherapy. ⋯ The 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.
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American heart journal · Apr 2019
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled trial to assess the efficAcy and safety of Trimetazidine in patients with angina pectoris having been treated by percutaneous coronary intervention (ATPCI study): Rationale, design, and baseline characteristics.
About 30% of angina patients have persisting symptoms despite successful revascularization and antianginal therapy. Moreover, in stable patients, percutaneous coronary intervention (PCI) does not improve survival as compared with medical therapy alone. Trimetazidine, an antianginal agent devoid of hemodynamic effect, may help reducing symptoms and improving outcomes after PCI. The ATPCI study is investigating the efficacy and safety of adding trimetazidine to standard-of-care in angina patients who had a recent PCI. ⋯ The ATPCI study will shed further light on the management of contemporary angina patients after PCI. Results are expected in 2019.
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American heart journal · Mar 2019
Randomized Controlled Trial Multicenter StudyImmediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial.
The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. ⋯ The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.
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American heart journal · Mar 2019
Randomized Controlled Trial Multicenter StudyDesign and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study.
The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. ⋯ The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.
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American heart journal · Jan 2019
Randomized Controlled Trial Multicenter Study Pragmatic Clinical TrialAn international cluster-randomized quality improvement trial to increase the adherence to evidence-based therapies for acute ischemic stroke and transient ischemic attack patients: Rationale and design of the BRIDGE STROKE Trial.
Translating evidence into clinical practice in the management of acute ischemic stroke (AIS) and transient ischemic attack (TIA) is challenging especially in low- and middle-income countries. ⋯ The BRIDGE Stroke Trial is an international pragmatic evaluation of a multifaceted quality improvement intervention. If effective, this intervention could be potentially extended widely to improve the quality of care and outcomes of patients with AIS or TIA.