Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Cardiac Disease Clinical Trial

Official title: Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

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 ;

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

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