Coronary Artery DiseaseNCT04619381
Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel
An observational study of Coronary Artery Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
African Americans with coronary artery disease who have been prescribed clopidogrel (also known as Plavix), an antiplatelet drug will be enrolled. The purpose of this study is to help identify why African Americans are at an increased risk of having a major heart attack or stroke after a common procedure to open up… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 19 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant population will be recruited from routine care clinic/physician visits
Who may be able to join
- 18 years of age or older
- Sex: Male and Female
- Race: Self-identified as African American
- History of percutaneous coronary intervention in the past 12 months
- Currently taking aspirin and clopidogrel for at least one month and up to one year
- English speaking
Who cannot join
- Use of nonsteroidal anti-inflammatory drugs
- Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Investigation of the Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel
African Americans with coronary artery disease who have been prescribed clopidogrel (also known as Plavix), an antiplatelet drug will be enrolled. The purpose of this study is to help identify why African Americans are at an increased risk of having a major heart attack or stroke after a common procedure to open up blocked arteries with stents. The knowledge to be gained from this study includes:
- A better understanding of the metabolism of the antiplatelet drug, clopidogrel, and abnormal platelet function in African Americans; this understanding may provide a basis for potential future therapy
- A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.
- Conditions
- Coronary Artery Disease
- Being tested
- CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY
- Keywords
- African American, Coronary Artery Disease, Anti Platelet
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEYBehavioural
Survey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance.
| Study group | Role | What they receive |
|---|---|---|
| African Americans with Coronary Artery Disease | African Americans with Coronary Artery Disease and currently taking clopidogrel Receives: Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma
Participant adherence to Plavix as measured by clopidogrel metabolite in plasma by liquid chromatography-tandem mass spectrometry. Clopidogrel non-adherence will be defined as plasma concentration of inactive carboxyl metabolite <5,000 ng/mL.
Measured: baseline
Clopidogrel resistance
Participant resistance to Plavix as measured by DNA analysis will be conducted to determine CYP2C19*2 loss of function (LOF) status. In addition, platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
Measured: baseline
Platelet function
Platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
Measured: baseline
Patient-level barriers to implementation of routine pharmacogenomic testing for antiplatelet therapy
Subjects will also complete a survey about clopidogrel adherence as well as their knowledge and attitudes about pharmacogenomic testing.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start19 Mar 2021
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Why it stopped: The study funding was dropped with no patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Aday, Vanderbilt University Medical Center
- Investigators
- Aaron Aday, MD, Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619381
- Sponsor's protocol ID
- 171699
- Status last verified
- Mar 2021
- First submitted
- 2 Nov 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel
- ClinicalTrials.gov ID
- NCT04619381
- Acronym / sponsor ID
- 171699
- Conditions
- Coronary Artery Disease
- Keywords
- African American, Coronary Artery Disease, Anti Platelet
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study funding was dropped with no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 6 Nov 2020 (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.
African Americans with coronary artery disease who have been prescribed clopidogrel (also known as Plavix), an antiplatelet drug will be enrolled. The purpose of this study is to help identify why African Americans are at an increased risk of having a major heart attack or stroke after a common procedure to open up blocked arteries with stents. The knowledge to be gained from this study includes:
- A better understanding of the metabolism of the antiplatelet drug, clopidogrel, and abnormal platelet function in African Americans; this understanding may provide a basis for potential future therapy
- A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African Americans with Coronary Artery Disease | – | Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEYAfrican Americans with Coronary Artery Disease and currently taking clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant population will be recruited from routine care clinic/physician visits
Key inclusion criteria (6 listed)
- 18 years of age or older
- Sex: Male and Female
- Race: Self-identified as African American
- History of percutaneous coronary intervention in the past 12 months
- Currently taking aspirin and clopidogrel for at least one month and up to one year
Key exclusion criteria (2 listed)
- Use of nonsteroidal anti-inflammatory drugs
- Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test
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 |
|---|---|---|
| CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEYSurvey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance. | Behavioural | African Americans with Coronary Artery Disease |
Primary outcome
Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma
Time frame: baseline
Participant adherence to Plavix as measured by clopidogrel metabolite in plasma by liquid chromatography-tandem mass spectrometry. Clopidogrel non-adherence will be defined as plasma concentration of inactive carboxyl metabolite <5,000 ng/mL.
Clopidogrel resistance
Time frame: baseline
Participant resistance to Plavix as measured by DNA analysis will be conducted to determine CYP2C19*2 loss of function (LOF) status. In addition, platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
Platelet function
Time frame: baseline
Platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
Patient-level barriers to implementation of routine pharmacogenomic testing for antiplatelet therapy
Time frame: baseline
Subjects will also complete a survey about clopidogrel adherence as well as their knowledge and attitudes about pharmacogenomic testing.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Aaron Aday, MD principal investigator
VUMC
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 Coronary Artery Disease, run by Vanderbilt University Medical Center 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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma (time frame: baseline). The study lists 4 primary outcomes in all. 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 1 Apr 2021.