Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

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.

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Key information

Conditions

Cardiac Disease Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients

Time frame: April 1, 2017 - April 1, 2018

To compare the incidence of MACE, stroke (ischemic and hemorrhage), MI (STEMI and NSTEMI), stent thrombosis, systemic embolism (VTE), death (all-cause, cardiac and non-cardiac) and CAD-associated hospitalizations/ED visits) in patients who received warfarin-based triple therapy versus NOAC-based triple therapy.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Mar 26, 2019
Registry last updated: Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed