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Antiplatelet Agent

Low-dose ticagrelor for Coronary Artery Disease

Phase 4

Recruiting

Led By Francesco Franchi, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ABCD-GENE score greater or equal than 10

Stable CAD undergoing elective PCI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial aims to compare the effects of two different medications, ticagrelor and clopidogrel, on blood platelets in patients with heart disease. We predict that ticagrelor will

Who is the study for?

This trial is for stable coronary artery disease patients undergoing elective heart procedure (PCI), aged 18 or older, with no recent heart attack and on low-dose aspirin plus clopidogrel. They must have a high genetic risk score (ABCD-GENE ≥10) and normal or slightly elevated troponin levels. Excluded are those with allergies to the drugs being tested, certain other medications, severe liver disease, low blood counts, potential bradycardia without a pacemaker, active bleeding issues, or women not using contraception.Check my eligibility

What is being tested?

The study compares the effects of two blood-thinning medications in preventing clot formation after PCI: Ticagrelor (60 mg twice daily) versus Clopidogrel. It aims to see if Ticagrelor offers better protection against platelet reactivity in high-risk genetic profile patients.See study design

What are the potential side effects?

Possible side effects include bleeding more easily than usual due to the medication's effect on platelets which can increase bruising and prolong bleeding times. There may also be risks of allergic reactions or interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ABCD-GENE score is 10 or higher.

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I have stable heart artery disease and am scheduled for a procedure to open my heart's arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

P2Y12 reaction units (PRU)

Secondary outcome measures

Maximum platelet aggregation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low-dose ticagrelorExperimental Treatment1 Intervention

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.

Group II: ClopidogrelActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ticagrelor 60mg

2020

Completed Phase 4

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,596 Total Patients Enrolled

44 Trials studying Coronary Artery Disease

30,100 Patients Enrolled for Coronary Artery Disease

Scott R. MacKenzie FoundationOTHER

4 Previous Clinical Trials

456 Total Patients Enrolled

4 Trials studying Coronary Artery Disease

456 Patients Enrolled for Coronary Artery Disease

Francesco Franchi, MDPrincipal InvestigatorUnivesrsity of Florida

5 Previous Clinical Trials

978 Total Patients Enrolled

4 Trials studying Coronary Artery Disease

942 Patients Enrolled for Coronary Artery Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently available to prospective participants?

"The current status of this study, as indicated on clinicaltrials.gov, shows that it is not actively seeking participants. The trial was initially posted on March 1st, 2024 and last edited on January 19th, 2024. However, it is worth noting that there are currently a total of 538 other ongoing trials actively recruiting patients."

Answered by AI

Has the United States Food and Drug Administration granted approval for low-dose ticagrelor usage?

"Our team at Power rates the safety of low-dose ticagrelor as a 3 on a scale from 1 to 3. This is because it is part of a Phase 4 trial, indicating that this treatment has already received approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06228456.

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