Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03889574
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2019-03-22
Brief Title:
Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
Sponsor:
Methodist Health System
Organization:
Methodist Health System
Study Overview
Official Title:
Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AimsObjectives
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 CADstent 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
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 CADstent 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 50109L
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
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 50109L
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None