Etrust trial

Outcome Measures. Thrombolysis in Myocardial Infarction TIMI defined bleeding events included: Major bleeding including fatal bleeding and non-fatal bleeding [fulfilling the TIMI major bleeding definition], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding defined as composite of major, minor, and minimal bleeding. The main efficacy endpoints were defined as the composite of cardiovascular death ARC , stroke protocol defined , systemic embolic event SEE , myocardial infarction MI , or definite stent thrombosis.

Study drug-related treatment-emergent adverse events TEAEs experienced by 2 or more participants were defined as events which started on or after first dose of the assigned study drug edoxaban and VKA or started prior to but then worsened after the first dose of the assigned study drug and were found to be related to treatment by the Investigator.

Eligibility Criteria. Inclusion Criteria: Oral anticoagulant OAC indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting.

Exclusion Criteria: Bleeding risks or systemic conditions Known bleeding diathesis, including but not limited to, Uncontrolled active bleeding, encompassing both ISTH major and clinically relevant non-major bleeding, preceding randomization. Concomitant conditions and therapies Critically ill or hemodynamically unstable subjects at the time of randomization including: cardiogenic shock or acute decompensated heart failure, with the requirement for vasopressor agents or inotropic support or mechanical support to support circulation respiratory failure requiring endotracheal intubation and mechanical ventilation.

Females taking oral contraceptives should have been on therapy for at least three months. Adequate contraceptives include: Combined estrogen and progestogen containing oral, intravaginal, transdermal, hormonal contraception associated with inhibition of ovulation; intrauterine device IUD ; intrauterine hormone-releasing system IUS ; bilateral tubal occlusion; vasectomized partner; sexual abstinence; Pregnant or breast-feeding participants; Assessment that the participant is not likely to comply with the study procedures or have complete follow-up; Participating in another clinical trial that potentially interferes with the current study; Previous randomization in this study; Active on prescription drug abuse and addiction; abuse of illicit substances i.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Camillo Forlanini - Ospedale S. More Information. Publications automatically indexed to this study by ClinicalTrials. Clin Res Cardiol. Epub Oct Epub Sep 3. Am Heart J. Keywords provided by Daiichi Sankyo, Inc.

National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Atrial Fibrillation.

Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Job Function Choose Job Level Choose Yemen Zambia Zimbabwe.

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