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Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation (SEARCH)

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ClinicalTrials.gov Identifier: NCT03746782
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
CirQuest Labs, LLC

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

Condition or disease Intervention/treatment
Acute Coronary Syndrome Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay

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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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigating Synergistic Effects of Apixaban With Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Apixaban combined with blood specimens (in vitro) of study participants

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

Healthy Donors
Apixaban combined with blood specimens (in vitro) from healthy participants
Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay
Apixaban combined with blood specimens (in vitro) of study participants




Primary Outcome Measures :
  1. Synergistic effects of in-vitro apixaban [ Time Frame: 1 day ]
    Synergistic effects of in-vitro apixaban with antiplatelet agents in inhibiting platelet reactivity and thrombin generation



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746782


Contacts
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Contact: Carol Hendrix, MSN, RN 901-866-1700 chendrix@cirquestlabs.com
Contact: Edward Hord, BSN, RN 901-866-1700 ehord@cirquestlabs.com

Locations
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United States, Tennessee
CirQuest Labs, LLC Recruiting
Memphis, Tennessee, United States, 38112
Contact: Carol Hendrix, MSN, RN    901-866-1700    chendrix@cirquestlabs.com   
Contact: Edward Hord, BSN, RN    901-866-1700    ehord@cirquestlabs.com   
Principal Investigator: Jayaprakash Kotha, PhD         
Sub-Investigator: Frank McGrew, MD         
Sub-Investigator: Lisa Jennings, PhD         
Sponsors and Collaborators
CirQuest Labs, LLC

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Responsible Party: CirQuest Labs, LLC
ClinicalTrials.gov Identifier: NCT03746782     History of Changes
Other Study ID Numbers: CV185-511 / CQ-15-10-005
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by CirQuest Labs, LLC:
Dual Anti-Platelet Therapy

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Apixaban
Thrombin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antipyretics
Antithrombins
Anticoagulants
Hemostatics
Coagulants