Coronary Artery DiseasePhase 4SWAP-8NCT06821191
Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study
A Phase 4 study testing clopidogrel 75 mg and Prasugrel 5 mg in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.
Trial summary
Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- clopidogrel 75 mg and Prasugrel 5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 7 Jan 2027
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin with either prasugrel (10 mg qd) or ticagrelor (90 mg bid) as part of standard of care. In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI.
- Age ≥18 years.
- Provide written informed consent.
Who cannot join
- Prior history of stent thrombosis
- Prior cerebrovascular event
- PCI within 30 days
- Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., *2/*2 or *3/*3),
- On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
- Hemodynamic instability
Show all 10Show fewer
- Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel
- Known hematologic malignancies or thrombocytopenia (platelet count <80x106/mL)
- Known hemoglobinopathies or anemia (hemoglobin <9 g/dL)
- Pregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study].
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Jacksonville, Florida, 32209
Luis Ortega, MD, PhD, 904-244-2060, Luis.Ortega@jax.ufl.edu
Andrea Burton, MPH, CCRP, 904-244-5617, Andrea.Burton@jax.ufl.edu
About this study
Official title: Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study
Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.
Read the detailed description
The combination of low-dose aspirin and a P2Y12 receptor inhibitor, commonly referred as dual antiplatelet therapy (DAPT), is guideline-recommended for preventing atherothrombotic events in patients experiencing an acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). In ACS patients undergoing PCI, DAPT is initiated at the time of the event and maintained for up to one year to mitigate the risks of stent-related complications and ischemic recurrences.4 There are 3 currently available oral P2Y12 inhibitors: clopidogrel, prasugrel, and ticagrelor. Among ACS patients undergoing PCI, prasugrel and ticagrelor are recommended over clopidogrel because of their enhanced efficacy in reducing ischemic events, including stent thrombosis. However, the increased antiplatelet potency of prasugrel and ticagrelor enhances the risk of bleeding, which has detrimental effects on the overall patient prognosis. The increased risk of mortality in patients experiencing bleeding events underscores the need for antiplatelet strategies that reduce bleeding risk while maintaining significant ischemic protection.
The majority of recurrent ischemic events, including stent thrombosis, tend to occur within the first 1 to 3 months after the index PCI procedure. As a result, in clinical practice it is common to use more potent antiplatelet therapies during the early (i.e., 1-3) months post-PCI, when platelet reactivity is heightened, and transition to therapies with lower platelet inhibition thereafter. This strategy, aimed at reducing bleeding risks while providing ischemic protections, is referred to as de-escalation and its implementation is supported by practice guidelines. In line with Academic Research Consortium (ARC) definitions, de-escalation can be implemented in 3 ways: a) by switching from a more potent to a less potent P2Y12 inhibitor; b) by dose reduction (e.g., lowering prasugrel or ticagrelor doses as an alternative to the initial regimen) or c) by stopping one antiplatelet drug (e.g., either the P2Y12 inhibitor or aspirin). Of the available de-escalation strategies, two of these allow patients to remain on a DAPT regimen maintaining the synergistic effect of targeting two different platelet activation pathways: de-escalation by switch and de-escalation by dose reduction. Notably, pharmacodynamic (PD) response to clopidogrel is characterized by a significant interindividual variability, which is partially mediated by specific alleles encoding the cytochrome P450 2C19. Thus, carriers of these alleles may be at increased risk of thrombotic events if a DAPT de-escalation by switch to clopdogrel is pursued.
In contrast, de-escalation by dose reduction has limited supporting evidence and low adoption in clinical practice. With a de-escalation by dose reduction strategy, patients remain on a potent P2Y12 inhibitor (i.e., prasugrel or ticagrelor) but at lower doses, which can reduce side effects, such as bleeding, without compromising efficacy, as these drugs have a more predictable PD response compared to clopidogrel. To date, clinical trial data on dose reduction after the early acute phase (i.e., 1-3 months) in patients with ACS undergoing PCI is limited and shown only with prasugrel. Notably, a recent head-to-head randomized controlled trial favoring prasugrel over ticagrelor, along with the availability of generic formulations of prasugrel, has led to a shift in antiplatelet prescriptions toward prasugrel. However, although there is extensive evidence comparing various de-escalation strategies with standard-of-care DAPT regimens, there are very few studies directly comparing de-escalation strategies with each other, setting the rationale for this investigation. To determine if the pharmcodynamic profiles of DAPT de-escalation by dose-reduction and by switching to clopidogrel are comparable, we aim to conduct a non-inferiority study.
- Conditions
- Coronary Artery Disease
- Being tested
- clopidogrel 75 mg, Prasugrel 5 mg
- Keywords
- Coronary artery disease, DAPT de-escalation, DAPT, dose-reduction, switch, clopidogrel, prasugrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel 75 mgDrug
Clopidogrel 75 mg od for 30 ± 5 days
Prasugrel 5 mgDrug
Prasugrel 5 mg od for 30 ± 5 days
| Study group | Role | What they receive |
|---|---|---|
| DAPT de-escalation by switch | Active comparator | Not described Receives: Drug: clopidogrel 75 mg |
| DAPT de-escalation by dose-reduction | Experimental | Not described Receives: Drug: Prasugrel 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity measured by VerifyNow
The primary endpoint of the study will be to establish non-inferiority by comparing PRU levels, determined using the VerifyNow system, between de-escalation through dose reduction to low-dose prasugrel (5 mg qd) and de-escalation through switching to standard-dose clopidogrel (75 mg qd) at trough levels.
Measured: 30±5 days
Secondary outcomes (1)
Platelet reactivity measured by VerifyNow
If non-inferiority is established, a superiority analysis will be conducted by comparing PRU levels, determined using the VerifyNow system, between de-escalation through dose reduction to low-dose prasugrel (5 mg qd) and de-escalation through switching to standard-dose clopidogrel (75 mg qd) at trough levels.
Measured: 30±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Mar 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed investigation will be a prospective, randomized, parallel-design, open-label study.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821191
- Sponsor's protocol ID
- IRB202401735
- Acronym
- SWAP-8
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erlinge D, Ten Berg J, Foley D, Angiolillo DJ, Wagner H, Brown PB, Zhou C, Luo J, Jakubowski JA, Moser B, Small DS, Bergmeijer T, James S, Winters KJ. Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial. J Am Coll Cardiol. 2012 Nov 13;60(20):2032-40. doi: 10.1016/j.jacc.2012.08.964. Epub 2012 Oct 17.
PubMed 23083774Erlinge D, Gurbel PA, James S, Lindahl TL, Svensson P, Ten Berg JM, Foley DP, Wagner H, Brown PB, Luo J, Zhou C, Moser BA, Jakubowski JA, Small DS, Winters KJ, Angiolillo DJ. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. J Am Coll Cardiol. 2013 Aug 13;62(7):577-83. doi: 10.1016/j.jacc.2013.05.023. Epub 2013 Jun 7.
PubMed 23747759Capodanno D, Mehran R, Krucoff MW, Baber U, Bhatt DL, Capranzano P, Collet JP, Cuisset T, De Luca G, De Luca L, Farb A, Franchi F, Gibson CM, Hahn JY, Hong MK, James S, Kastrati A, Kimura T, Lemos PA, Lopes RD, Magee A, Matsumura R, Mochizuki S, O'Donoghue ML, Pereira NL, Rao SV, Rollini F, Shirai Y, Sibbing D, Smits PC, Steg PG, Storey RF, Ten Berg J, Valgimigli M, Vranckx P, Watanabe H, Windecker S, Serruys PW, Yeh RW, Morice MC, Angiolillo DJ. Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium. Circulation. 2023 Jun 20;147(25):1933-1944. doi: 10.1161/CIRCULATIONAHA.123.064473. Epub 2023 Jun 19.
PubMed 37335828
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study
- ClinicalTrials.gov ID
- NCT06821191
- Acronym / sponsor ID
- SWAP-8 / IRB202401735
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, DAPT de-escalation, DAPT, dose-reduction, switch, clopidogrel, prasugrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 11 Feb 2025 (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.
Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.
Detailed description
The combination of low-dose aspirin and a P2Y12 receptor inhibitor, commonly referred as dual antiplatelet therapy (DAPT), is guideline-recommended for preventing atherothrombotic events in patients experiencing an acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). In ACS patients undergoing PCI, DAPT is initiated at the time of the event and maintained for up to one year to mitigate the risks of stent-related complications and ischemic recurrences.4 There are 3 currently available oral P2Y12 inhibitors: clopidogrel, prasugrel, and ticagrelor. Among ACS patients undergoing PCI, prasugrel and ticagrelor are recommended over clopidogrel because of their enhanced efficacy in reducing ischemic events, including stent thrombosis. However, the increased antiplatelet potency of prasugrel and ticagrelor enhances the risk of bleeding, which has detrimental effects on the overall patient prognosis. The increased risk of mortality in patients experiencing bleeding events underscores the need for antiplatelet strategies that reduce bleeding risk while maintaining significant ischemic protection.
The majority of recurrent ischemic events, including stent thrombosis, tend to occur within the first 1 to 3 months after the index PCI procedure. As a result, in clinical practice it is common to use more potent antiplatelet therapies during the early (i.e., 1-3) months post-PCI, when platelet reactivity is heightened, and transition to therapies with lower platelet inhibition thereafter. This strategy, aimed at reducing bleeding risks while providing ischemic protections, is referred to as de-escalation and its implementation is supported by practice guidelines. In line with Academic Research Consortium (ARC) definitions, de-escalation can be implemented in 3 ways: a) by switching from a more potent to a less potent P2Y12 inhibitor; b) by dose reduction (e.g., lowering prasugrel or ticagrelor doses as an alternative to the initial regimen) or c) by stopping one antiplatelet drug (e.g., either the P2Y12 inhibitor or aspirin). Of the available de-escalation strategies, two of these allow patients to remain on a DAPT regimen maintaining the synergistic effect of targeting two different platelet activation pathways: de-escalation by switch and de-escalation by dose reduction. Notably, pharmacodynamic (PD) response to clopidogrel is characterized by a significant interindividual variability, which is partially mediated by specific alleles encoding the cytochrome P450 2C19. Thus, carriers of these alleles may be at increased risk of thrombotic events if a DAPT de-escalation by switch to clopdogrel is pursued.
In contrast, de-escalation by dose reduction has limited supporting evidence and low adoption in clinical practice. With a de-escalation by dose reduction strategy, patients remain on a potent P2Y12 inhibitor (i.e., prasugrel or ticagrelor) but at lower doses, which can reduce side effects, such as bleeding, without compromising efficacy, as these drugs have a more predictable PD response compared to clopidogrel. To date, clinical trial data on dose reduction after the early acute phase (i.e., 1-3 months) in patients with ACS undergoing PCI is limited and shown only with prasugrel. Notably, a recent head-to-head randomized controlled trial favoring prasugrel over ticagrelor, along with the availability of generic formulations of prasugrel, has led to a shift in antiplatelet prescriptions toward prasugrel. However, although there is extensive evidence comparing various de-escalation strategies with standard-of-care DAPT regimens, there are very few studies directly comparing de-escalation strategies with each other, setting the rationale for this investigation. To determine if the pharmcodynamic profiles of DAPT de-escalation by dose-reduction and by switching to clopidogrel are comparable, we aim to conduct a non-inferiority study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed investigation will be a prospective, randomized, parallel-design, open-label study.
| Arm | Type | Receives |
|---|---|---|
| DAPT de-escalation by switch | Active comparator | Drug: clopidogrel 75 mg |
| DAPT de-escalation by dose-reduction | Experimental | Drug: Prasugrel 5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin with either prasugrel (10 mg qd) or ticagrelor (90 mg bid) as part of standard of care. In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI.
- Age ≥18 years.
- Provide written informed consent.
Key exclusion criteria (10 listed)
- Prior history of stent thrombosis
- Prior cerebrovascular event
- PCI within 30 days
- Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., *2/*2 or *3/*3),
- On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrel 75 mgClopidogrel 75 mg od for 30 ± 5 days | Drug | DAPT de-escalation by switch |
| Prasugrel 5 mgPrasugrel 5 mg od for 30 ± 5 days | Drug | DAPT de-escalation by dose-reduction |
Primary outcome
Platelet reactivity measured by VerifyNow
Time frame: 30±5 days
The primary endpoint of the study will be to establish non-inferiority by comparing PRU levels, determined using the VerifyNow system, between de-escalation through dose reduction to low-dose prasugrel (5 mg qd) and de-escalation through switching to standard-dose clopidogrel (75 mg qd) at trough levels.
1 secondary outcome
Platelet reactivity measured by VerifyNow
Time frame: 30±5 days
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 12 May 2026.
- Background: PubMed 23083774Erlinge D, Ten Berg J, Foley D, Angiolillo DJ, Wagner H, Brown PB, Zhou C, Luo J, Jakubowski JA, Moser B, Small DS, Bergmeijer T, James S, Winters KJ. Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial. J Am Coll Cardiol. 2012 Nov 13;60(20):2032-40. doi: 10.1016/j.jacc.2012.08.964. Epub 2012 Oct 17.
- Background: PubMed 23747759Erlinge D, Gurbel PA, James S, Lindahl TL, Svensson P, Ten Berg JM, Foley DP, Wagner H, Brown PB, Luo J, Zhou C, Moser BA, Jakubowski JA, Small DS, Winters KJ, Angiolillo DJ. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. J Am Coll Cardiol. 2013 Aug 13;62(7):577-83. doi: 10.1016/j.jacc.2013.05.023. Epub 2013 Jun 7.
- Background: PubMed 37335828Capodanno D, Mehran R, Krucoff MW, Baber U, Bhatt DL, Capranzano P, Collet JP, Cuisset T, De Luca G, De Luca L, Farb A, Franchi F, Gibson CM, Hahn JY, Hong MK, James S, Kastrati A, Kimura T, Lemos PA, Lopes RD, Magee A, Matsumura R, Mochizuki S, O'Donoghue ML, Pereira NL, Rao SV, Rollini F, Shirai Y, Sibbing D, Smits PC, Steg PG, Storey RF, Ten Berg J, Valgimigli M, Vranckx P, Watanabe H, Windecker S, Serruys PW, Yeh RW, Morice MC, Angiolillo DJ. Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium. Circulation. 2023 Jun 20;147(25):1933-1944. doi: 10.1161/CIRCULATIONAHA.123.064473. Epub 2023 Jun 19.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel 75 mg and Prasugrel 5 mg in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Luis Ortega, MD, PhD (904-244 2060, Luis.Ortega@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity measured by VerifyNow (time frame: 30±5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821191, which also lists 3 linked publications.
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 12 May 2026.