Coronary Artery DiseasePhase 4NCT06228456
Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
A Phase 4 study testing Ticagrelor 60mg and Clopidogrel in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.
Trial summary
The proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). 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?
- Ticagrelor 60mg and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Apr 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
- Stable CAD undergoing elective PCI;
- Male or females, Age ≥ 18 years old;
- Troponin negative before coronary angiography;
- On treatment with low-dose aspirin (81mg od) and clopidogrel for at least 24 hours after index PCI;
- ABCD-GENE score greater or equal than 10.
- Troponin negative is defined as hs-cTn below the URL for the laboratory (Male < 22 ng/L; Female < 14 ng/L) or modestly positive hs-cTn (Male: 22-99 ng/L; Female: 14-99 ng/L) flat or decreasing from hour 0 to 3.
Who cannot join
- Myocardial infarction at the time of index PCI;
- On treatment with prasugrel or ticagrelor;
- Documented hypersensitivity to clopidogrel;
- Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) in the prior 24 hours;
- Concomitant therapy with strong CYP3A4 inhibitors or CYP3A4 substrates;
- Use of oral anticoagulant therapy;
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- History of previous intracerebral bleed at any time;
- Active pathological bleeding;
- Documented hypersensitivity to ticagrelor;
- Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker;
- Known severe liver disease;
- Known platelet count <80x106/mL;
- Known hemoglobin <9 g/dL;
- Women of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR who have a positive pregnancy test at enrollment or randomization OR women who are breast-feeding.
- Inability to provide written informed consent.
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
Jacksonville, Florida, 32209
Francesco Franchi, MD
About this study
Official title: Pharmacodynamic Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention Who Are At Risk of Peri-PCI Myocardial Infarction Using a Precision Medicine Tool
The proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better pharmacodynamic effects (i.e., lower platelet reactivity and high platelet reactivity rates) compared with clopidogrel in stable coronary artery disease patients undergoing percutaneous coronary intervention with a high ABCD-GENE score.
Read the detailed description
Clopidogrel is the P2Y12 inhibitor of choice in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI). However, clopidogrel effects are subject to variability and 30-40% of patients have high platelet reactivity (HPR), which translates into higher rates of thrombotic complications. Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI. Importantly, these events are associated with poor prognosis, including cardiovascular mortality. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. A precision medicine tool integrating clinical (age, body mass index, chronic kidney disease and diabetes) and genetic (CYP2C19 loss-of-function allele status) factors called ABCD-GENE is able to identify HPR status. This score helps characterize patients at risk for peri-PCI thrombotic complications, who can thus potentially benefit from changes in antiplatelet treatment regimen. The new generation oral P2Y12 inhibitors prasugrel and ticagrelor are more potent than clopidogrel and associated with lower HPR rates and improved outcomes. Hence, these agents may be beneficial in reducing peri-PCI myocardial infarction/myocardial injury. Standard-dose ticagrelor (90 mg bid) provides more potent antiplatelet effect than clopidogrel in patients with ACS. Low-dose ticagrelor (60 mg bid) is beneficial in patients with prior myocardial infarction and has the potential of better bleeding profile compared to standard dose.This prospective randomized study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better PD effects (i.e., lower platelet reactivity and HPR rates) compared with clopidogrel in stable CAD patients undergoing PCI with a high ABCD-GENE score.
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor 60mg, Clopidogrel
- Keywords
- platelet reactivity, antiplatelet therapy
- 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.
Ticagrelor 60mgDrug
Also called Brilinta
Patients in the ticagrelor arm will receive a 180 mg loading dose of ticagrelor followed by ticagrelor 60 mg bid maintenance dose for 30±5 days. Patients will maintain aspirin 81 mg once daily for the duration of the study.
ClopidogrelDrug
Also called Plavix
Patients in the clopidogrel arm will continue to receive clopidogrel 75 mg/daily for 30±5 days. Patients will maintain aspirin 81 mg once daily for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose ticagrelor | Experimental | Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel. Receives: Drug: Ticagrelor 60mg |
| Clopidogrel | Active comparator | Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
P2Y12 reaction units (PRU)
The primary endpoint will be platelet reactivity measured by VerifyNow PRU
Measured: 30 days
Secondary outcomes (1)
Maximum platelet aggregation
Platelet aggregation will be measured using light transmittance aggregometry (LTA) with 20 μmol/L ADP as stimuli
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Scott R. MacKenzie Foundation
- Responsible party
- Sponsor
- Investigators
- Francesco Franchi, MD, Principal investigator, Univesrsity of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228456
- Sponsor's protocol ID
- IRB202302083
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention Who Are At Risk of Peri-PCI Myocardial Infarction Using a Precision Medicine Tool
- ClinicalTrials.gov ID
- NCT06228456
- Acronym / sponsor ID
- IRB202302083
- Conditions
- Coronary Artery Disease
- Keywords
- platelet reactivity, antiplatelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Scott R. MacKenzie Foundation
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 Jan 2024 (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 proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better pharmacodynamic effects (i.e., lower platelet reactivity and high platelet reactivity rates) compared with clopidogrel in stable coronary artery disease patients undergoing percutaneous coronary intervention with a high ABCD-GENE score.
Detailed description
Clopidogrel is the P2Y12 inhibitor of choice in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI). However, clopidogrel effects are subject to variability and 30-40% of patients have high platelet reactivity (HPR), which translates into higher rates of thrombotic complications. Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI. Importantly, these events are associated with poor prognosis, including cardiovascular mortality. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. A precision medicine tool integrating clinical (age, body mass index, chronic kidney disease and diabetes) and genetic (CYP2C19 loss-of-function allele status) factors called ABCD-GENE is able to identify HPR status. This score helps characterize patients at risk for peri-PCI thrombotic complications, who can thus potentially benefit from changes in antiplatelet treatment regimen. The new generation oral P2Y12 inhibitors prasugrel and ticagrelor are more potent than clopidogrel and associated with lower HPR rates and improved outcomes. Hence, these agents may be beneficial in reducing peri-PCI myocardial infarction/myocardial injury. Standard-dose ticagrelor (90 mg bid) provides more potent antiplatelet effect than clopidogrel in patients with ACS. Low-dose ticagrelor (60 mg bid) is beneficial in patients with prior myocardial infarction and has the potential of better bleeding profile compared to standard dose.This prospective randomized study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better PD effects (i.e., lower platelet reactivity and HPR rates) compared with clopidogrel in stable CAD patients undergoing PCI with a high ABCD-GENE score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose ticagrelor | Experimental | Drug: Ticagrelor 60mgStable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel. |
| Clopidogrel | Active comparator | Drug: ClopidogrelStable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stable CAD undergoing elective PCI;
- Male or females, Age ≥ 18 years old;
- Troponin negative before coronary angiography;
- On treatment with low-dose aspirin (81mg od) and clopidogrel for at least 24 hours after index PCI;
- ABCD-GENE score greater or equal than 10.
Key exclusion criteria (15 listed)
- Myocardial infarction at the time of index PCI;
- On treatment with prasugrel or ticagrelor;
- Documented hypersensitivity to clopidogrel;
- Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) in the prior 24 hours;
- Concomitant therapy with strong CYP3A4 inhibitors or CYP3A4 substrates;
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 |
|---|---|---|
| Ticagrelor 60mgAlso: BrilintaPatients in the ticagrelor arm will receive a 180 mg loading dose of ticagrelor followed by ticagrelor 60 mg bid maintenance dose for 30±5 days. Patients will maintain aspirin 81 mg once daily for the duration of the study. | Drug | Low-dose ticagrelor |
| ClopidogrelAlso: PlavixPatients in the clopidogrel arm will continue to receive clopidogrel 75 mg/daily for 30±5 days. Patients will maintain aspirin 81 mg once daily for the duration of the study. | Drug | Clopidogrel |
Primary outcome
P2Y12 reaction units (PRU)
Time frame: 30 days
The primary endpoint will be platelet reactivity measured by VerifyNow PRU
1 secondary outcome
Maximum platelet aggregation
Time frame: 30 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 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Francesco Franchi, MD principal investigator
Univesrsity of Florida
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 Ticagrelor 60mg and Clopidogrel 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 6 inclusion and 15 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 5 Feb 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 Francesco Franchi, MD (9042442060, francesco.franchi@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P2Y12 reaction units (PRU) (time frame: 30 days). 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 5 Feb 2026.