Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
NCT ID: NCT03889574
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
84 participants
OBSERVATIONAL
2019-02-26
2019-06-27
Brief Summary
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* 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
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* 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
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Locations
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Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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References
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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.
Other Identifiers
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071.PHA.2018.D
Identifier Type: -
Identifier Source: org_study_id