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P2Y12 Inhibitor

Ticagrelor vs Clopidogrel for Coronary Artery Disease (SWAP-AC-2 Trial)

Phase 4

Waitlist Available

Led By Dominick J Angiolillo, MD, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care

Must not have

Known severe liver dysfunction or any known hepatic disease associated with coagulopathy

Any active bleeding or history of major bleeding

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 is testing whether the drug ticagrelor is more effective than clopidogrel in reducing the risk of thrombotic events (blood clots) in patients who are also taking oral anticoagulants (blood thinners). A total of 63 patients will be enrolled and given either ticagrelor or clopidogrel. The trial will assess the pharmacodynamic effects of both drugs to determine which is more effective.

Who is the study for?

Adults over 18 who've had successful PCI and are on dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) and an oral anticoagulant for any reason. They must not be in other drug studies, have major bleeding issues, severe liver disease, recent strokes, life-threatening non-cardiovascular diseases, end-stage renal disease on dialysis, or allergies to the study drugs.

What is being tested?

The trial is testing how well two blood-thinning medications—Ticagrelor and Clopidogrel—work in patients with coronary artery disease who also need oral anticoagulation after PCI. It aims to see if one is better at preventing platelets from clumping together using a scoring system called ABCD-GENE.

What are the potential side effects?

Possible side effects include bleeding problems since both Ticagrelor and Clopidogrel prevent blood clotting. There may also be risks of bruising easily, shortness of breath or allergic reactions. The exact side effects will vary between individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had a successful heart stent placement and am on blood thinning medication.

Exclusion Criteria

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

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I have severe liver problems or a liver disease that affects my blood clotting.

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I have no active bleeding or history of major bleeding.

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I am allergic or react badly to clopidogrel or ticagrelor.

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I am not currently taking strong medication for fungal infections or HIV.

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I am on dialysis for end-stage kidney disease.

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I have had a bleeding stroke or brain bleed in the past.

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I have a serious health condition besides heart disease that could worsen with the study treatment.

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

Platelet reactivity measured as PRU

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

3Treatment groups

Experimental Treatment

Active Control

Group I: ABCD-GENE >10 - TicagrelorExperimental Treatment1 Intervention

Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.

Group II: ABCD-GENE >10 - ClopidogrelActive Control1 Intervention

Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.

Group III: ABCD-GENE <10 - ClopidogrelActive Control1 Intervention

Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ticagrelor 60mg

2020

Completed Phase 4

~40

0 / 9Eligibility criteria met