NCT05960721Recruiting
Low-dose NOAC Versus GDMT After LAAO
Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial
Source: ClinicalTrials.gov · Last updated 27 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Data from randomized trials, including PROTECT-AF, PREVAIL, and Prague-17, have suggested that LAAO has comparable efficacy to warfarin or NOACs. Considering these results, LAAO was recommended by the American College of Cardiology (ACC) and European Society of Cardiology (ESC) guidelines as a non-pharmacological stroke prevention strategy for patients with NVAF who have contraindications or are unsuitable for OAC. The PROTECT-AF and PREVAIL trials stipulated the use of standardized antithrombotic medications which were designed to minimize the risk of stroke, systemic embolism, or device-related thrombosis. This antithrombotic strategy was subsequently endorsed by the guidelines, briefly, patients with LAAO were discharged on warfarin and aspirin for 45 days post-LAAO, if there was no leak or a leak ≤5 mm under transesophageal echocardiography (TEE) at 45-day follow-up, antithrombotic strategies shall switch to dual antiplatelet therapy (DAPT) until 6 months post-LAAO, and then aspirin thereafter. Although LAAO was recommended by medical societies, previous patient-level meta-analyses have implied that compared with oral anticoagulation, LAAO had significantly more ischemic strokes, suggesting the inability of LAAO to prevent an ischemic stroke from sources beyond LAA. Will a combined strategy of LAAO and OAC further reduce the risk of stroke? The investigators hypothesized that a long-term low dose-Rivaroxaban (10mg daily) post-LAAO might be a potent supplement to the residue risk of ischemic stroke.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 4220 (estimated)
- First submitted
- 28 Jun 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Xijing Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05960721
What you commit to
- Study type: Interventional
- Planned participants: 4220
- From 6 Jul 2023 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- Concurrent medical condition with a life expectancy of less than two years
- Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
- The patient had or is planning to have any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., PCI, cardioversion, cardiac surgery)
- Previous stroke/TIA within 30 days of enrolment
Other illness
- Ongoing overt bleeding
- Symptomatic carotid artery disease
- Severe renal insufficiency (CrCl≤30ml/min/1.73m2)
Age
- Under the age of 18
Other
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- Haemodynamical unstable
- Peridevice leak \> 5mm as assessed immediately after LAAO or any other procedure-related complications
- Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted mechanical valve)
- Percutaneous coronary intervention (PCI) within 1 year.
Who the study is looking for
- Non-valvular atrial fibrillation (NVAF) patients with successful left atrial appendage occlusion (LAAO)
- Eligible for guideline-directed anti-thrombotic therapy
- Able to understand and provide informed consent and comply with all study medications
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ling Tao Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.