Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation

Completed

Conditions studied: Acute Coronary Syndrome

In brief

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

Key facts

Study ID

NCT03746782

Run by

CirQuest Labs, LLC

People needed

40

Starts

2018-07-10

Expected to finish

2019-11-08

Last updated by the study team

2020-01-23

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provision of informed consent prior to any study specific procedures (i.e., venipuncture).
• Male or female at least 18 years of age but equal to or less than 75 years of age.
• Females must be post-menopausal for at least one year or surgically sterile for at least 6 months.
• For ACS Subjects:
• Documented prior history of ACS within the past 12 months.
• 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.
• Have taken DAPT medication for at least 7 days as prescribed prior to blood collection.
• For Healthy Subjects:
• Currently not prescribed and/or taking any of the excluded medications listed in Exclusion Criteria #4.

You may not qualify if…

• Male or female less than 18 or greater than 75 years of age.
• No prior history of ACS within 12 months (unless Healthy Subject)
• Pregnancy
• 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®)
• Diagnosed with or possessing significant renal dysfunction as defined by the physician/investigator.

Where it is running

• CirQuest Labs, LLC — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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