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Antiplatelet Agent

Ticagrelor vs. Clopidogrel 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

Must not have

Use of oral anticoagulant therapy

Known severe liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking blood thinners.

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I have a severe liver condition.

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I am currently taking prasugrel or ticagrelor.

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I had a heart attack when I received my stent placement.

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I am not taking strong CYP3A4 inhibitors or substrates.

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I have had a brain bleed in the past.

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I am currently experiencing uncontrolled bleeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

P2Y12 reaction units (PRU)

Secondary study objectives

Maximum platelet aggregation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met