Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention

NCT06228456 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB202302083
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease

Keywords

platelet reactivity; antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• P2Y12 reaction units (PRU)

  The primary endpoint will be platelet reactivity measured by VerifyNow PRU

  30 days

Secondary Outcomes (1)

• Maximum platelet aggregation

  30 days

Study Arms (2)

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.

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.

Drug: Clopidogrel

Interventions

Ticagrelor 60mg DRUG

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.

Also known as: Brilinta

Low-dose ticagrelor

Clopidogrel DRUG

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.

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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;
• 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.

Sponsors & Collaborators

• University of Florida: lead
• Scott R. MacKenzie Foundation: collaborator

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Francesco Franchi, MD

  Univesrsity of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Franchi, MD

CONTACT

9042442060; francesco.franchi@jax.ufl.edu

Andrea Burton, MPH, CPH

CONTACT

9042445617; andrea.burton@jax.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)