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P2Y12 Inhibitor
Prasugrel vs Ticagrelor for Coronary Artery Disease (SWAP-7 Trial)
Phase 4
Waitlist Available
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
Age between 18 and 75 years old
Be older than 18 years old
Must not have
History of stroke/TIA
Age > 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21±7 days
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to compare the effectiveness of two different medications, ticagrelor and prasugrel, in preventing blood clots after a heart procedure. The goal is to see if these two
Who is the study for?
This trial is for individuals with coronary artery disease who have undergone a procedure to open their heart's blood vessels. Participants should not be on dual antiplatelet therapy but instead need to switch to a single potent platelet blocker.
What is being tested?
The study compares two single antiplatelet therapies: Prasugrel (10 mg) and Ticagrelor (90 mg), after heart vessel surgery, to see which one prevents blood clots better without causing too many bleeding problems.
What are the potential side effects?
Possible side effects include bleeding more easily than normal, shortness of breath, headache, dizziness, nausea or allergic reactions. Each person may experience these differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stroke or a transient ischemic attack (TIA).
Select...
I am over 75 years old.
Select...
I weigh less than 60 kg.
Select...
I have had bleeding in my brain.
Select...
I have severe liver problems.
Select...
I have a known blood clotting disorder.
Select...
I am currently taking blood thinners for a blood clot.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21±7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21±7 days
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 by VerifyNow
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prasugrel monotherapyExperimental Treatment1 Intervention
Prasugrel 10 mg qd for 21±7 days
Group II: Ticagrelor monotherapyActive Control1 Intervention
Ticagrelor 90 mg bid monotherapy for 21±7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prasugrel 10 mg
2010
Completed Phase 4
~110
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,404 Previous Clinical Trials
766,282 Total Patients Enrolled
45 Trials studying Coronary Artery Disease
30,293 Patients Enrolled for Coronary Artery Disease
Francesco Franchi, MDPrincipal InvestigatorUniversity of Florida College of Medicine Jacksonville
6 Previous Clinical Trials
1,028 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
992 Patients Enrolled for Coronary Artery Disease