Phase 4
N=30
Platelet Inhibition in Patients With Systolic Heart Failure
Systolic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01765400 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: The Change in Platelet Aggregation Measured by the Accumetrics (VerifyNow P2Y12) Assay Between Baseline and Each Antiplatelet Medication — 66.4; 156.2 PRU (P2Y12 reactivity units) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prasugrel 10 mg daily x 2 weeks (Drug); Clopidogrel 75 mg daily x 2 weeks (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Platelet Aggregation Measured by the Accumetrics (VerifyNow P2Y12) Assay Between Baseline and Each Antiplatelet Medication |
66.4; 156.2 | <0.05 sig |
| SECONDARY The Change in Light Transmission Aggregometry (LTA)Between Baseline and Each Antiplatelet Medication |
32; 47; 38; 54 | — |
| SECONDARY The Change in Platelet Activation Assay (VASP)Between Baseline and Each Antiplatelet Medication |
25; 49 | — |
Summary
The investigators aim to determine if patients with systolic heart failure treated with prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.
Eligibility Criteria
Inclusion Criteria
- Patients 19 to 74 years of age.
- Patients with a left ventricular ejection fraction 1.4
- Patients with liver function tests (AST or ALT) > 2 times normal
- Patients with a suspected change in their use of aspirin during the study (starting, stopping, or changing dose of aspirin)
- Patients unwilling to consent to CYP2C19 genetic testing.
Data sourced from ClinicalTrials.gov (NCT01765400). 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.