Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

NCT03889574 | Completed

• 1 other identifier: 071.PHA.2018.D
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease

Keywords

ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Related Publications (1)

• 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.

  PMID: 20837828 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 26, 2019
• Study Start: February 26, 2019
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

US (1)