Triple Antithrombotic Therapy in Cardiac Patients Requiring

Status Completed

Clinical Trial Summary

Aim(s)/Objective(s) - To evaluate the safety and efficacy of triple antithrombotic therapy in patients taking DAPT of aspirin and a P2Y12 inhibitor in addition to either a NOAC or warfarin for the prevention of thromboembolic or acute coronary syndrome (ACS) events in patients with non-valvular atrial fibrillation (AF), history of coronary artery disease (CAD)/stent placement or recurrent ACS event. - To determine the Methodist Health System (MHS) prescribing practices and patterns in cardiac patients with a history of AF who are admitted for CAD or an ACS event requiring PCI. Hypothesis Primary Hypothesis Cardiac patients with a history of AF and an indication for long-term NOAC who are also prescribed DAPT following an ASC event or revascularization with stenting will demonstrate a significant difference in cardiovascular outcomes and major bleeding events when compared with warfarin-based triple therapy.

Clinical Trial Description

STUDY DESIGN - Multi-center, retrospective cohort chart review study design - Data will be collected on all triple therapy recipients who were discharged from a Methodist Health System (MHS) facility with prescriptions for a combination of aspirin, P2Y12 Inhibitor and an OAC of either a NOAC or warfarin between April 1, 2017 - April 1, 2018 - Patient list will be generated in EPIC - All data will be obtained from EPIC - All data will be collected retrospectively after the patient is discharged from the hospital - Data collection (planned completion date): May 2019 Study Inclusion Criteria: - 18 years or older - AF diagnosis - ICD10 for ACS, STEMI or NSTEMI - Discharged with triple therapy agents of aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), and OAC (warfarin, edoxaban, dabigatran, rivaroxaban, or apixaban) status post-stent Study Exclusion Criteria: - Patients less than 18 years of age - Prior intracranial bleeding prior to study start date - GI hemorrhage within 1 month prior to study start date - Major bleeding event with 1 month prior to study start date - Hemorrhage disorder - Stroke within 1 month prior to study start date - Cardiogenic shock during admission at start date - Contraindication to use of the study medications - Peptic ulcer in the prior 6 months prior to study start date - Thrombocytopenia (platelet concentration lower than 50×109/L) - Thrombolysis In Myocardial Infarction (TIMI) major bleeding in the prior 12 months of study start date - Pregnancy - History of DVT or PE currently on OAC ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03889574
Study type	Observational
Source	Methodist Health System
Contact
Status	Completed
Phase
Start date	February 26, 2019
Completion date	June 27, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms