Phase 4
N=34
A Pharmacodynamic Study With Ticagrelor in African American Patients
Stable Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01523392 ↗Enrolled (actual)
34
Serious AEs
1.5%
Results posted
Sep 2014
Primary outcome: Primary: Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose — 27.6; 211.2 PRU — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose |
27.6; 211.2 | <0.001 sig |
| SECONDARY Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose |
166.3; 270.1; 27.2; 192.6 | <0.001 sig |
| SECONDARY Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 |
22.9; 157.8; 28.5; 146.5; 39.3; 172.7 | <0.001 sig |
| SECONDARY Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses |
1.0; 1.2; 206.6; 33.7; 1167.3; 756.9 | — |
| SECONDARY AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses |
1.0; 1.0; 9.8; 2.3; 222.6; 150.9 | — |
Summary
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent before initiation of any study-related procedures
- Male or female patients aged 18 years or older
- Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
- Females must be post menopausal or surgically sterile Self-identified as African American
Exclusion Criteria
- Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
- Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
- Current smokers, including the use of tobacco containing products in the past 1 month of randomization Patients required dialysis
Data sourced from ClinicalTrials.gov (NCT01523392). 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.