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Prasugrel monotherapy 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
1. Patients on DAPT with aspirin plus prasugrel 10 mg or ticagrelor 90 mg bid as per standard of care at least 90 days after PCI.
2. Age between 18 and 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21±7 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
Ticagrelor currently represents the most tested and commonly used P2Y12 inhibitor monotherapy following percutaneous coronary intervention. The purpose of this study is to conduct a head-to-head comparison on the pharmacodynamic efficacy of ticagrelor-based and prasugrel-based single antiplatelet therapy. To determine if the PD profiles of ticagrelor- and prasugrel-based SAPT are comparable, we aim to conduct a non-inferiority study between the two strategies.
Eligible Conditions
- Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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
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.
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
1,399 Previous Clinical Trials
767,031 Total Patients Enrolled
45 Trials studying Coronary Artery Disease
30,150 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
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