Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03889574

Enrollment

Registered

2019-03-26

Start date

2019-02-26

Completion date

2019-06-27

Last updated

2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation

Brief 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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients	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.

Countries

United States

Outcome results