N/A
N=509
Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention
Acute Coronary Syndrome · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02508116 ↗Enrolled (actual)
509
Serious AEs
49.0%
Results posted
Nov 2018
Primary outcome: Primary: The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor — 174; 201; 75; 54 Participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CYP2C19 genotyping (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor |
174; 201; 75; 54 | 0.03 sig |
| SECONDARY Number of Participants With Drug Orders in Agreement With the Genotype-guided Recommendations |
172; 133 | — |
| SECONDARY Number of Participants With Major Cardiac Events |
34; 26 | 0.27 |
| SECONDARY Number of Participants With Bleeding Events |
6; 7 | — |
Summary
This is a randomized, prospective, open label study to determine the cost-effectiveness of genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI) with stent implantation, will be randomized either to genotype guided dosing of antiplatelet therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, ≥18 to ≤80 years at time of study
- Status post PCI with stent implantation requiring antiplatelet therapy
- Willingness to comply with all study-related procedures
Exclusion Criteria
- Pending imminent surgery placing patients at increased risk for bleeding with prasugrel or ticagrelor.
- History of intracranial hemorrhage, TIA, and stroke
- Active bleeding
- Need for long-term anticoagulation (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or lovenox).
- Current or prior (within the past four weeks) treatment with voraxapar (Zontivity).
- Severe renal or hepatic impairment
- Treating physician does not want subject to participate
- Drug allergy to clopidogrel, prasugrel or ticagrelor.
Data sourced from ClinicalTrials.gov (NCT02508116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.