Cardiac DiseaseNCT03889574
Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
An observational study of Cardiac Disease, run by Methodist Health System at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 27 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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.
Read the 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 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
- Cardiac Disease
- Keywords
- ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation
- Medical subject headings
- Heart Diseases, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 1, 2017 - April 1, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start26 Feb 2019
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889574
- Sponsor's protocol ID
- 071.PHA.2018.D
- Status last verified
- Nov 2020
- First submitted
- 22 Mar 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20837828
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization
- ClinicalTrials.gov ID
- NCT03889574
- Acronym / sponsor ID
- 071.PHA.2018.D
- Conditions
- Cardiac Disease
- Keywords
- ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- • 18 years or older
Key exclusion criteria (13 listed)
- • Patients less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 20837828Hansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients (time frame: April 1, 2017 - April 1, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.