Evaluation of a Single Measurement Strategy for Direct Oral Anticoagulants in Frail Older Patients with Atrial Fibrillation or Venous Thromboembolism

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What is this study about?

This study aims to evaluate the effectiveness of a Single Measurement and adjustment strategy for Direct Oral Anticoagulants (DOACs) in frail older individuals with atrial fibrillation or venous thromboembolism. DOACs are medications that help prevent blood clots from forming. Atrial fibrillation is an irregular heartbeat condition that can lead to blood clots, while venous thromboembolism refers to blood clots that form in veins.

The research focuses on frail older patients over 70 years of age who are taking DOACs. Frailty is a condition characterized by reduced strength, endurance, and physiological function that increases vulnerability to health problems. The study will measure the levels of DOACs in participants’ blood and make adjustments to their medication dosage when necessary.

The researchers will track whether this strategy reduces complications such as bleeding events or thromboembolic events (blood clots that can travel through the bloodstream). Ischemic stroke (when a blood vessel supplying blood to the brain is blocked), transient ischemic accident (TIA) (a temporary period of symptoms similar to a stroke), and peripheral thromboembolism (blood clots in vessels away from the heart and brain) will be monitored as part of the study.

1 Beginning the Study

After joining the study, you’ll be evaluated to confirm your eligibility. The study focuses on participants who are over 70 years old, currently using a Direct Oral Anticoagulant (DOAC) medication, have a Clinical Frailty Scale score greater than 3, are able to visit the outpatient clinic (if living in the community), and can provide informed consent.

DOACs are blood-thinning medications that help prevent blood clots. The study will include patients taking edoxaban, apixaban, dabigatran etexilate, or rivaroxaban.

2 Group Assignment

You’ll be randomly assigned to either a standard care group or an intervention group. This is done by chance, similar to flipping a coin.

If you’re in the intervention group, you’ll participate in the Single Measurement and adjustment strategy, which involves measuring the level of DOAC medication in your blood and potentially adjusting your dosage based on the results.

3 Blood Sampling and Medication Review

During the study, blood samples will be taken to measure the level of DOAC medication in your system.

If you’re in the intervention group and your DOAC levels are found to be outside the target range, your medication dosage may be adjusted to bring it within the optimal range.

4 Follow-up Period

Throughout the study, which runs until September 2025, you’ll be monitored for any health events, particularly focusing on blood clots or bleeding complications.

Blood clot events being tracked include ischemic stroke (blockage of blood flow to the brain), transient ischemic accident (TIA, a temporary stroke-like event), and peripheral thromboembolism (blood clots in other parts of the body).

Bleeding events being tracked include major bleeding or clinically relevant non-major bleeding, based on international medical standards.

5 Quality of Life Assessment

During the study, you’ll be asked to complete questionnaires about your quality of life. These help researchers understand how the different approaches to DOAC management affect your daily living and overall wellbeing.

6 Study Completion

The study is scheduled to end in September 2025. After the study concludes, the researchers will analyze all the data collected to determine if the Single Measurement and adjustment strategy leads to better outcomes for older frail patients taking DOAC medications.

The analysis will look at whether the strategy reduces complications, whether certain factors are associated with abnormal DOAC levels, the strategy’s impact on quality of life, its practicality, cost-effectiveness, and its effect on mortality.

Who Can Join the Study?

You must be over 70 years old
You must be using a DOAC (Direct Oral Anticoagulant – a type of blood-thinning medication)
You must have a Clinical Frailty Scale (CFS) score greater than 3 (this means you have some level of frailty or vulnerability in your daily functioning)
If you live in the community (not in a care facility), you must be able to visit the outpatient clinic
You must be able to provide informed consent (understand the study and agree to participate)
Preferably, you should be new to DOAC treatment (just starting this medication)
You must have atrial fibrillation (irregular heartbeat) or venous thromboembolism (blood clots in veins)

Who Cannot Join the Study?

Being under 75 years of age
Not having atrial fibrillation (irregular heartbeat) or venous thromboembolism (blood clots in veins)
Not currently taking a DOAC (Direct Oral Anticoagulant – a type of blood-thinning medication)
Not being considered frail (having reduced physical function and vulnerability to health problems)
Having severe kidney failure
Having active cancer requiring treatment
Having a life expectancy of less than 1 year
Being unable to provide informed consent
Being pregnant or breastfeeding
Having participated in another clinical trial within the past 30 days
Having a known allergy or sensitivity to the study medications
Having active bleeding or high risk of bleeding that would make blood-thinning medications unsafe

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Envida	Maastricht	The Netherlands

Other Sites

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Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Direct Oral Anticoagulants (DOACs) are blood-thinning medications used to prevent blood clots from forming or growing larger in your blood vessels. They work by inhibiting specific proteins in your blood that are involved in the clotting process. These medications are commonly prescribed to reduce the risk of stroke in people with certain heart conditions or to treat and prevent blood clots in the legs and lungs.

Investigated diseases:

Atrial Fibrillation – A heart condition characterized by irregular and often rapid heart rate that occurs when the two upper chambers of the heart beat irregularly and out of coordination with the two lower chambers. During atrial fibrillation, the heart’s upper chambers beat chaotically and irregularly, out of sync with the lower chambers. This condition can lead to blood clots forming in the heart, which may circulate to other organs and cause blocked blood flow. The condition often progresses gradually, starting with brief episodes that become longer and more persistent over time.

Venous Thromboembolism – A condition where a blood clot forms in a vein, most commonly in the deep veins of the legs (deep vein thrombosis), and can travel through the bloodstream to the lungs (pulmonary embolism). The condition typically begins with the formation of a blood clot in a deep vein, often after periods of immobility or due to certain medical conditions that increase blood clotting. If part of the clot breaks off, it can travel through the bloodstream and lodge in blood vessels in the lungs, creating a potentially serious blockage. Venous thromboembolism can be recurrent, with patients experiencing multiple episodes over time.

Trial ID:

2025-521362-10-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Evaluation of a Single Measurement Strategy for Direct Oral Anticoagulants in Frail Older Patients with Atrial Fibrillation or Venous Thromboembolism

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?