Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Completed

• Conditions: Cardiac Disease

• Registration Number: NCT03889574
• Lead Sponsor: Methodist Health System

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

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States