NCT04010955Active, not recruiting
Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)
The Role of Additional Antiplatelet Therapy in the Ischemic Stroke With Atrial Fibrillation and Co-morbiD Atherosclerosis During edOxaban treatmeNt. (ADD-ON) Study, Multicenter Registry-based Analysis
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
This study aims to compare the effectiveness and safety regarding treatment with standard anticoagulant only or adding antiplatelet to anticoagulant in patients with non-valvular atrial fibrillation and significant atherosclerosis including extracranial, intracranial, coronary or peripheral artery.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 24 Jun 2019
- Start date
- 8 Oct 2019
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- Asan Medical Center
- Diseases
- Coronary artery disease, Stroke, Atrial fibrillation
- NCT number
- NCT04010955
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 8 Oct 2019 to the primary completion date, 27 Jun 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
- patients requiring warfarin medication due to prosthetic valve replacement
- History of acute myocardial infarction or received coronary artery procedure within 6 months before screening
- Patients who have received or are scheduled to undergo carotid stenting within 1 year
Other illness
- patients with internal bleeding (active internal bleeding)
- bleeding diathesis
- Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure
- Patients who are scheduled for invasive surgery with possible uncontrolled bleeding, including major surgery
Lab values
- Patients with chronic renal failure (GFR \<30 ml / min) or severe liver damage
- A person who is found to be unsuitable for participation in the study due to the clinical laboratory test results or other reasons
Other
- Currently, two or more antiplatelet agents are required due to arteriosclerosis.
- Women who are pregnant or lactating, do not have contraception during the study
Who the study is looking for
- Patients with acute cerebral infarction or transient ischemic attack within 14 days of symptom onset based on Last Known Normal Time.
- Patients with non-valvular atrial fibrillation including paroxysmal atrial fibrillation which is eligible for treatment with Edoxaban.
- Patients with significant atherosclerosis confirmed by imaging tests on the cerebral arteries, coronary arteries, or peripheral arteries and suitable for the use of antiplatelet agents.
- Significant intracranial internal stenosis confirmed by CTA or MRA
- A history of coronary artery disease, meaningful findings from CTA or CAG Arterial stenosis
- Peripheral arterial disease (Ankle-Brachial Index, ABI \<0.9, significant stenosis found in lower limb ultrasonography
- 3\) Men and women over 20 years old 4) Patients who voluntarily agreed to register the registry
Age in the registry: 20 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 |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.