Clinical trial NCT03889574: Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
Official title: Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients
timeFrame: April 1, 2017 - April 1, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
References:
citation: 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.