Atrial FibrillationNCT07724301
Regulation of Platelet Function in Older Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation and Thrombotic Risk, run by University of Michigan.
Trial summary
The goal of this observational study is to learn about the effects of antiplatelet drugs on patients over the age of 80 with atrial fibrillation. The main question it aims to answer is: -Is platelet reactivity effectively controlled in patients over the age of 80 diagnosed with atrial fibrillation following the… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation, Thrombotic Risk
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of patients over the age of 80 who have been diagnosed with atrial fibrillation and will receive the Watchman Procedure and receive antiplatelet drugs following procedure.
Who may be able to join
- diagnosed with atrial fibrillation, scheduled for a Watchman Procedure
Who cannot join
- Healthy, taking antiplatelet medication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn about the effects of antiplatelet drugs on patients over the age of 80 with atrial fibrillation. The main question it aims to answer is:
-Is platelet reactivity effectively controlled in patients over the age of 80 diagnosed with atrial fibrillation following the Watchman procedure.
Read the detailed description
Cardiovascular disease remains the leading cause of death and the risk for morbidity and mortality due to cardiovascular disease is thought to increases with age. Platelets play a key role in cardiovascular disease as their activation is essential for the formation of an arterial thrombus, the precursor to myocardial infarction and stroke. Additionally, thrombosis has been shown to be linked to cardiac pathologies including atrial fibrillation. The link between optimal prevention of thrombosis and limiting the risk associated with increased bleeding has not been fully elucidated. Hence, our understanding of the prothrombotic state of the platelet and thrombotic risk in people over the age of 80 is not well understood. In this study, we evaluate the prothrombotic state of the platelets in patients in the cardiovascular clinic over the age of 80 diagnosed with atrial fibrillation who are taking antiplatelet medications to determine the benefits of these interventions in prevention of thrombotic events, propagation of the risk for atrial fibrillation, and bleeding
- Conditions
- Atrial Fibrillation, Thrombotic Risk
- Keywords
- atrial fibrillation, thrombosis, bleeding, elderly over 80, antiplatelet drugs, aspirin, clopidogrel, platelet function
- Medical subject headings
- Atrial Fibrillation, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with atrial fibrillation over the age of 80 | Patients over the age of 80 diagnosed with atrial fibrillation receiving ether aspirin alone or aspirin and clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
platelet reactivity will be measured before and after antiplatelet treatment in patients over 80. Outcomes will include 1) platelet aggregation, 2) integrin activation, 3) alpha and dense granule secretion, 4) T-TAS activation, and 5) TEG.
Measured: blood draw will occur prior to Watchman procedure and antiplatelet administration and 90 days following Watchman procedure while patients are taking antiplatelet drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Holinstat, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724301
- Sponsor's protocol ID
- HUM00295130
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD information will be made available on a request basis and determination will be made with HIPAA policies being taken into consideration and the treating physician.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Platelet Function in Older Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07724301
- Acronym / sponsor ID
- HUM00295130
- Conditions
- Atrial Fibrillation, Thrombotic Risk
- Keywords
- atrial fibrillation, thrombosis, bleeding, elderly over 80, antiplatelet drugs, aspirin, clopidogrel, platelet function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Jul 2026 (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.
The goal of this observational study is to learn about the effects of antiplatelet drugs on patients over the age of 80 with atrial fibrillation. The main question it aims to answer is:
-Is platelet reactivity effectively controlled in patients over the age of 80 diagnosed with atrial fibrillation following the Watchman procedure.
Detailed description
Cardiovascular disease remains the leading cause of death and the risk for morbidity and mortality due to cardiovascular disease is thought to increases with age. Platelets play a key role in cardiovascular disease as their activation is essential for the formation of an arterial thrombus, the precursor to myocardial infarction and stroke. Additionally, thrombosis has been shown to be linked to cardiac pathologies including atrial fibrillation. The link between optimal prevention of thrombosis and limiting the risk associated with increased bleeding has not been fully elucidated. Hence, our understanding of the prothrombotic state of the platelet and thrombotic risk in people over the age of 80 is not well understood. In this study, we evaluate the prothrombotic state of the platelets in patients in the cardiovascular clinic over the age of 80 diagnosed with atrial fibrillation who are taking antiplatelet medications to determine the benefits of these interventions in prevention of thrombotic events, propagation of the risk for atrial fibrillation, and bleeding
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with atrial fibrillation over the age of 80 | – | –Patients over the age of 80 diagnosed with atrial fibrillation receiving ether aspirin alone or aspirin and clopidogrel |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of patients over the age of 80 who have been diagnosed with atrial fibrillation and will receive the Watchman Procedure and receive antiplatelet drugs following procedure.
Key inclusion criteria (1 listed)
- diagnosed with atrial fibrillation, scheduled for a Watchman Procedure
Key exclusion criteria (1 listed)
- Healthy, taking antiplatelet medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet reactivity
Time frame: blood draw will occur prior to Watchman procedure and antiplatelet administration and 90 days following Watchman procedure while patients are taking antiplatelet drugs
platelet reactivity will be measured before and after antiplatelet treatment in patients over 80. Outcomes will include 1) platelet aggregation, 2) integrin activation, 3) alpha and dense granule secretion, 4) T-TAS activation, and 5) TEG.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. IPD information will be made available on a request basis and determination will be made with HIPAA policies being taken into consideration and the treating physician.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thrombotic Risk, run by University of Michigan.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Holinstat, PhD (734-764-4046, mholinst@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (time frame: blood draw will occur prior to Watchman procedure and antiplatelet administration and 90 days following Watchman procedure while patients are taking antiplatelet drugs). 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 25 Sep 2026.