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Antiplatelet

Antiplatelet Therapy for Coronary Heart Disease (SWAP-9 Trial)

Phase 4
Waitlist Available
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
Patients who have undergone PCI and are on maintenance treatment with DAPT, composed of low-dose aspirin (81mg qd) with either prasugrel (10 mg qd) or ticagrelor (90 mg bid). In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI
Must not have
Hemodynamic instability
Pregnant and breastfeeding women (women of childbearing age must use reliable birth control, i.e., oral contraceptives, while participating in the study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30±5 days (trough levels)
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial aims to compare the effects of using a genetic test to guide the adjustment of medication versus adjusting medication without the test in patients who have had a heart procedure.

Who is the study for?
This trial is for individuals with coronary heart disease who have undergone a procedure to open their heart's arteries, known as PCI. Participants should be currently on dual antiplatelet therapy but cannot join if they have conditions that the study doesn't allow.
What is being tested?
The SWAP-9 Study is testing whether it's better to choose post-PCI medication based on genetic information (ABCD-GENE guided) or not. It compares staying on standard drugs (aspirin and clopidogrel) versus switching to either Prasugrel or Ticagrelor alone.
What are the potential side effects?
Possible side effects include bleeding risks, allergic reactions, shortness of breath, headache, high blood pressure, nausea, dizziness, and increased cholesterol levels.

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 had a stent placed in my heart and take specific heart medications daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure and heart rate are stable.
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I am not pregnant or breastfeeding and use birth control.
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I am currently taking blood thinners for a blood clot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30±5 days (trough levels)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30±5 days (trough levels) 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)

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: ABCD-GENE-guided de-escalationExperimental Treatment1 Intervention
ABCD-GENE ≥10: prasugrel 10 mg qd or ticagrelor 90 mg od monotherapy. ABCD-GENE \<10: Aspirin 81 mg qd and clopidogrel 75 mg qd.
Group II: Unguided de-escalationActive Control1 Intervention
Aspirin 81 mg qd and clopidogrel 75 mg qd.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,399 Previous Clinical Trials
766,989 Total Patients Enrolled
~60 spots leftby Aug 2026
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