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Trial record 14 of 509 for:    ASPIRIN AND P2

Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889574
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Brief Summary:

1.2. 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.

1.4. Hypothesis 1.4.1. 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.


Condition or disease
Cardiac Patients With Atrial Fibrillation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort
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



Primary Outcome Measures :
  1. Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients [ Time Frame: April 1, 2017 - April 1, 2018 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889574


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 CrysteeCooper@mhd.com
Contact: Nitasha Phatak, Ph.D. 214-947-4459 NitashaPhatak@mhd.com

Sponsors and Collaborators
Methodist Health System

Publications:
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT03889574     History of Changes
Other Study ID Numbers: 071.PHA.2018.D
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Methodist Health System:
ICD10 for ACS, STEMI or NSTEMI, with triple therapy agents of aspirin, P2Y12 inhibitorand OAC status post-stent
Additional relevant MeSH terms:
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Aspirin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics