Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation

NCT03746782 | Completed

• 1 other identifier: CV185-511 / CQ-15-10-005
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Coronary Syndrome

Keywords

Dual Anti-Platelet Therapy

Outcome Measures

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

  1 day

Study Arms (3)

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

Flow Cytrometry; Thrombin Generation Assay DIAGNOSTIC_TEST

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

ACS using clopidogrel + aspirin; ACS using ticagrelor + aspirin; Healthy Donors

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

You may not qualify if:

• Have taken DAPT medication for at least 7 days as prescribed prior to blood collection.
• For Healthy Subjects:
• 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)

Sponsors & Collaborators

• CirQuest Labs, LLC: lead

Study Sites (1)

CirQuest Labs, LLC

Memphis, Tennessee, 38112, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: November 20, 2018
• Study Start: July 10, 2018
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

US (1)