Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Cardiac Disease Clinical Trial

Official title:

Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889574
• Other study ID #: 071.PHA.2018.D
• Status: Completed
• Start date: February 26, 2019
• Est. completion date: June 27, 2019

Study information

• Verified date: November 2020
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hansen ML, Sørensen R, Clausen MT, Fog-Petersen ML, Raunsø J, Gadsbøll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrøm SZ, Poulsen HE, Køber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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