Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Methodist Health System

Status: Completed

Conditions: Cardiac Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03889574

071.PHA.2018.D

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

84 participants in 2 patient groups

combination of aspirin, P2Y12 Inhibitor with a NOAC

Description:

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

Description:

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