Device-Related ThrombosisPhase 4FADE-DRTNCT04502017
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
A Phase 4 study testing ASA plus Clopidogrel, Genetic-Tailored AntiThrombotic Strategy and Half-Dose of novel OAC in people with Device-Related Thrombosis and Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device-Related Thrombosis, Atrial Fibrillation, Left Atrial Appendage Occlusion
- What is being tested?
- ASA plus Clopidogrel, Genetic-Tailored AntiThrombotic Strategy and Half-Dose of novel OAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 31 Dec 2023
- Phase
- Phase 4
- 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
Who may be able to join
- Men and women ≥18 years of age
- Successful LAAC procedure (device implanted without procedural or bleeding complication).
- Patients contraindicated or unsuitable for long-term OAC.
- History of AF (permanent or persistent or paroxysmal).
- Written informed consent by the patient or designee if the patient is unable to consent
Who cannot join
- Life expectancy < 2 years.
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. David's Medical Center
Austin, Texas, 78705
Andrea Natale, MD, andrea.natale@stdavids.com
Domenico G Della Rocca, MD, 7375296806, domenicodellarocca@hotmail.it
About this study
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Read the detailed description
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
- Being tested
- ASA plus Clopidogrel, Genetic-Tailored AntiThrombotic Strategy, Half-Dose of novel OAC
- Keywords
- left atrial appendage, Watchman, antithrombotic therapy, device-related thrombosis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA plus ClopidogrelDrug
OAC (6 weeks) + DAPT (until 6 months) + ASA
Genetic-Tailored AntiThrombotic StrategyDrug
Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
Half-Dose of novel OACDrug
Half Dose of novel OAC post-device Implantation
| Study group | Role | What they receive |
|---|---|---|
| Standard Antithrombotic Therapy | Active comparator | OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone Receives: Drug: ASA plus Clopidogrel |
| Genetic-Tailored AntiThrombotic Strategy | Active comparator | OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone Receives: Drug: Genetic-Tailored AntiThrombotic Strategy |
| Half-Dose NOAC | Active comparator | Half Dose of Novel OAC Receives: Drug: Half-Dose of novel OAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
Measured: 1 year
Incidence of Major Bleeding Events
Measured: 1 year
Secondary outcomes (1)
Incidence of Minor Bleeding Events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start5 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device-Related ThrombosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502017
- Sponsor's protocol ID
- TCAI_LAAO
- Acronym
- FADE-DRT
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT04502017
- Acronym / sponsor ID
- FADE-DRT / TCAI_LAAO
- Keywords
- left atrial appendage, Watchman, antithrombotic therapy, device-related thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Aug 2020 (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.
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Detailed description
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Antithrombotic Therapy | Active comparator | Drug: ASA plus ClopidogrelOAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone |
| Genetic-Tailored AntiThrombotic Strategy | Active comparator | Drug: Genetic-Tailored AntiThrombotic StrategyOAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone |
| Half-Dose NOAC | Active comparator | Drug: Half-Dose of novel OACHalf Dose of Novel OAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ≥18 years of age
- Successful LAAC procedure (device implanted without procedural or bleeding complication).
- Patients contraindicated or unsuitable for long-term OAC.
- History of AF (permanent or persistent or paroxysmal).
- Written informed consent by the patient or designee if the patient is unable to consent
Key exclusion criteria (3 listed)
- Life expectancy < 2 years.
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA plus ClopidogrelOAC (6 weeks) + DAPT (until 6 months) + ASA | Drug | Standard Antithrombotic Therapy |
| Genetic-Tailored AntiThrombotic StrategyHalf-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype | Drug | Genetic-Tailored AntiThrombotic Strategy |
| Half-Dose of novel OACHalf Dose of novel OAC post-device Implantation | Drug | Half-Dose NOAC |
Primary outcome
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
Time frame: 1 year
Incidence of Major Bleeding Events
Time frame: 1 year
1 secondary outcome
Incidence of Minor Bleeding Events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ASA plus Clopidogrel, Genetic-Tailored AntiThrombotic Strategy and Half-Dose of novel OAC in people with Device-Related Thrombosis and Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico G Della Rocca, MD (7375296806, domenicodellarocca@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2020.