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CompletedNCT03746782SEARCHUpdated Jan 23, 2020

Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation

An observational study in Acute Coronary Syndrome, sponsored by CirQuest Labs, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by CirQuest Labs, LLC · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 74 Years
Sex
All
01

Study summary

Investigating Synergistic Effects of Apixaban with Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation

Read the 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.

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Conditions studied

  • Acute Coronary Syndrome

Keywords

  • Dual Anti-Platelet Therapy
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 40 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

CirQuest Labs, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

30 subjects with ACS diagnosis and dual anti-platelet therapy requirements and 10 healthy subjects; no restrictions on gender, race or ethnicity; ages 18-74, non-childbearing potential for females.

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 Exclusion Criteria #4.

Exclusion criteria

Exclusion Criteria:

  1. Male or female less than 18 or greater than 75 years of age.
  2. No prior history of ACS within 12 months (unless Healthy Subject)
  3. Pregnancy

  4. Currently prescribed and/or taking any of the following medications:

    Within the last 1 month:

    • PAR-1 antagonist (vorapaxar/Zontivity®)
    • Coumadin®
    • Heparin including low molecular weight heparin (enoxaparin/Lovenox®)
    • Factor Xa inhibitors (rivaroxaban/Xarelto®, apixaban/Eliquis®, edoxaban/Savaysa®, betrixaban/Bevyxxa®)
    • Direct thrombin inhibitors (hirudin, bivalirudin/Angiomax®, dabigatran/Pradaxa®)

    Within last 10 days:

    • Glycoprotein IIb/IIIa inhibitors (Eptifibatide/Integrilin®, Tirofiban/Aggrastat®, Abciximab/ReoPro®)
    • Acetylsalicylic Acid/Aspirin products (Alka-Seltzer®, Goody Powder®, BC Powder®, Pepto Bismol®, Aggrenox®) (except aspirin as prescribed for DAPT participants)

    Within last 3 days:

    • Phosphodiesterase inhibitors (cilostazol/Pletal®)
    • Adenosine reuptake inhibitors (dipyridamole/Persantine®)
    • NSAIDs
    • Decongestants
    • Antidepressants or Anti-anxiety medications:
    • Selective Serotonin Reuptake Inhibitors (SSRI) (fluoxetine/Prozac®, sertraline/Zoloft®, paroxetine/Paxil®)
    • Selective Norepinephrine Reuptake Inhibitors (SNRI) (venlafaxine/Effexor® or duloxetine/Cymbalta®)
  5. Diagnosed with or possessing significant renal dysfunction as defined by the physician/investigator.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • ACS using clopidogrel + aspirin

    Apixaban combined with blood specimens (in vitro) from Acute Coronary Syndrome participants prescribed a regimen of DAPT in the form of clopidogrel + aspirin

    Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay

  • ACS using ticagrelor + aspirin

    Apixaban combined with blood specimens (in vitro) from Acute Coronary Syndrome participants prescribed a regimen of DAPT in the form of ticagrelor + aspirin

    Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay

  • Healthy Donors

    Apixaban combined with blood specimens (in vitro) from healthy participants

    Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay

Interventions

  • Diagnostic testFlow Cytrometry; Thrombin Generation Assay

    Apixaban combined with blood specimens (in vitro) of study participants

06

What researchers measure

Primary outcomes

  1. Synergistic effects of in-vitro apixaban

    Synergistic effects of in-vitro apixaban with antiplatelet agents in inhibiting platelet reactivity and thrombin generation

    Time frame: 1 day

07

Study locations

1 site
  • CirQuest Labs, LLC
    Memphis, Tennessee 38112, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03746782
Lead sponsor
CirQuest Labs, LLC
Responsible party
Sponsor
First posted
Nov 20, 2018
Start date
Jul 10, 2018
Primary completion
Nov 8, 2019
Completion
Nov 8, 2019
Last update
Jan 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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