Acute Coronary SyndromeSEARCHNCT03746782
Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation
An observational study of Acute Coronary Syndrome, run by CirQuest Labs, LLC at 1 site in United States.
Trial summary
Investigating Synergistic Effects of Apixaban with Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Flow Cytrometry; Thrombin Generation Assay
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 8 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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®)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Synergistic Effects of Apixaban With Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Flow Cytrometry; Thrombin Generation Assay
- Keywords
- Dual Anti-Platelet Therapy
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Cytrometry; Thrombin Generation AssayDiagnostic test
Apixaban combined with blood specimens (in vitro) of study participants
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay | |
| Healthy Donors | Apixaban combined with blood specimens (in vitro) from healthy participants Receives: Diagnostic Test: Flow Cytrometry; Thrombin Generation Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synergistic effects of in-vitro apixaban
Synergistic effects of in-vitro apixaban with antiplatelet agents in inhibiting platelet reactivity and thrombin generation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start10 Jul 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CirQuest Labs, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746782
- Sponsor's protocol ID
- CV185-511 / CQ-15-10-005
- Acronym
- SEARCH
- Status last verified
- Jan 2020
- First submitted
- 11 Jul 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Synergistic Effects of Apixaban With Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation
- ClinicalTrials.gov ID
- NCT03746782
- Acronym / sponsor ID
- SEARCH / CV185-511 / CQ-15-10-005
- Conditions
- Acute Coronary Syndrome
- Keywords
- Dual Anti-Platelet Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CirQuest Labs, LLCUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACS using clopidogrel + aspirin | – | Diagnostic Test: Flow Cytrometry; Thrombin Generation AssayApixaban combined with blood specimens (in vitro) from Acute Coronary Syndrome participants prescribed a regimen of DAPT in the form of clopidogrel + aspirin |
| ACS using ticagrelor + aspirin | – | Diagnostic Test: Flow Cytrometry; Thrombin Generation AssayApixaban combined with blood specimens (in vitro) from Acute Coronary Syndrome participants prescribed a regimen of DAPT in the form of ticagrelor + aspirin |
| Healthy Donors | – | Diagnostic Test: Flow Cytrometry; Thrombin Generation AssayApixaban combined with blood specimens (in vitro) from healthy participants |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- For Healthy Subjects:
Key exclusion criteria (22 listed)
- 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:
- Diagnosed with or possessing significant renal dysfunction as defined by the physician/investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow Cytrometry; Thrombin Generation AssayApixaban combined with blood specimens (in vitro) of study participants | Diagnostic test | ACS using clopidogrel + aspirin, ACS using ticagrelor + aspirin, Healthy Donors |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by CirQuest Labs, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synergistic effects of in-vitro apixaban (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.