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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease

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

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
combination of aspirin, P2Y12 Inhibitor with a NOAC; As this is a retrospective study with limited patients available for the cohort, all patients meeting inclusion criteria from April 1, 2017 - April 1, 2018 will be included to obtain the largest sample size possible
combination of aspirin, P2Y12 Inhibitor with warfarin; As this is a retrospective study with limited patients available for the cohort, all patients meeting inclusion criteria from April 1, 2017 - April 1, 2018 will be included to obtain the largest sample size possible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients	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.	April 1, 2017 - April 1, 2018

Collaborators and Investigators

• Sponsor: Methodist Health System

Publications and helpful links

General Publications

• Hansen ML, Sorensen R, Clausen MT, Fog-Petersen ML, Raunso J, Gadsboll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrom SZ, Poulsen HE, Kober L, Torp-Pedersen C. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med. 2010 Sep 13;170(16):1433-41. doi: 10.1001/archinternmed.2010.271.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2019
• Primary Completion (ACTUAL): June 27, 2019
• Study Completion (ACTUAL): June 27, 2019

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 071.PHA.2018.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No