Atrial Fibrillation study: Half-Dose of novel OAC vs Low-dose ASA
Official title Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
ClinicalTrials.gov ID: NCT07840365
What this study is testing
What is Half-Dose of novel OAC?
This is an investigational dosing strategy for apixaban being studied to help prevent blood clots in people with atrial fibrillation. It is designed to reduce the formation of blood clots by interfering with a specific protein in the blood clotting process.
Also referred to as apixaban.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see which blood‑thinner schedule is safer and works better after a Watchman implant.
- Who it's for
- Adults who have had a Watchman device placed for atrial fibrillation.
- What's involved
- Participants will take either a lower dose of apixaban for a long time or aspirin for a long time, after an initial 45‑day period of full‑dose apixaban.
- Time commitment
- The study lasts for the long term after the initial 45‑day period, with follow‑up visits as needed.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women ≥18 years of age;
- Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding...
- Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization,
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
You likely can't join if
- Two or more clinical characteristics at baseline (age≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL) requiring apixaban dosage adjustment;
- Mechanical heart valves or valvular disease requiring surgery or treatment procedure;
- Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk);
- Any contra-indication or known allergy to aspirin or clopidogrel or apixaban;
- Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism);
- Ongoing major bleeding or complicated or recent (\<72hours) major surgery;
See the full eligibility criteria
- Men and women ≥18 years of age;
- Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding complication) within a day or are scheduled to undergo the LAAO procedure
- Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization,
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Two or more clinical characteristics at baseline (age≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL) requiring apixaban dosage adjustment;
- Mechanical heart valves or valvular disease requiring surgery or treatment procedure;
- Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk);
- Any contra-indication or known allergy to aspirin or clopidogrel or apixaban;
- Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism);
- Ongoing major bleeding or complicated or recent (\<72hours) major surgery;
- Recent myocardial infarction (\<6 weeks);
- Recent TE event (\<6 weeks)
- Recent Intracranial bleeding (\< 6 months);
- Prasugrel or ticagrelor concomitant use
- Participating in an investigational drug or another device trial within the previous 30 days;
- High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical;
- Pregnancy or within 48 hours post-partum or breast feeding women;
- Patient under legal protection.
The study team makes the final eligibility decision.
Where it is enrolling
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.