Acute Coronary Syndrome
Conditions
Keywords
Dual Anti-Platelet Therapy
Brief summary
Investigating Synergistic Effects of Apixaban with Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation
Detailed description
Combination anti-platelet therapies particularly those combining aspirin with a P2Y12 antagonist (DAPT) are regarded as the current standard of care therapy for patients with Acute Coronary Syndrome (ACS). As thrombin potently induces platelet dense granular release and causes secondary adenosine 5'-diphosphate (ADP)-mediated P2Y12 receptor activation, apixaban via inhibition of thrombin generation may exhibit synergistic activity with direct P2Y12 receptor blockers such as clopidogrel or ticagrelor. The results from the study will provide a clearer understanding of how these antithrombotic agents work in combination and how the anti-Xa, apixaban, may reduce the contribution of thrombin and general platelet reactivity when used alone and in combination with antiplatelet agents. This study does NOT involve administration of medication to subjects. Experiments will be performed on donated blood samples from participants.
Interventions
DIAGNOSTIC_TESTFlow Cytrometry; Thrombin Generation Assay
Apixaban combined with blood specimens (in vitro) of study participants
Sponsors
CirQuest Labs, LLC
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures (i.e., venipuncture). 2. Male or female at least 18 years of age but equal to or less than 75 years of age. 3. Females must be post-menopausal for at least one year or surgically sterile for at least 6 months. 4. For ACS Subjects: 1. Documented prior history of ACS within the past 12 months. 2. Currently prescribed a DAPT medication regimen of aspirin (81mg) plus a P2Y12 inhibitor, clopidogrel or ticagrelor, and none of the excluded medications listed in
Exclusion criteria
#4. 3. Have taken DAPT medication for at least 7 days as prescribed prior to blood collection. 5. For Healthy Subjects: 1. Currently not prescribed and/or taking any of the excluded medications listed in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Synergistic effects of in-vitro apixaban | 1 day | Synergistic effects of in-vitro apixaban with antiplatelet agents in inhibiting platelet reactivity and thrombin generation |
Countries
United States
Outcome results
None listed