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New treatment option for Coronary Artery Disease
Official title Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT06228456
What this study is testing
What is Ticagrelor 60mg?
Ticagrelor 60mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for coronary artery disease.
Also referred to as Brilinta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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;
See the full eligibility criteria
- 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)...
- 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;
- 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...
- Inability to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.