Acute Coronary SyndromeAA GeneticNCT01408121
African-American Pharmacogenetics
An observational study of Acute Coronary Syndrome, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a genetic and platelet reactivity study of African-American versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2016
- 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: African-american versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel.
Who may be able to join
- Patients age 18 or older, of both genders
- Presenting with an ACS, defined as at least two of the following:
- symptoms consistent with myocardial ischemia;
- ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG;
- a cardiac troponin I level above upper limit of normal.
- Self-reported African-american or Caucasian race
Show all 9Show fewer
- all 4 grandparents of same race
- No contraindications to prasugrel therapy.
- Patient is scheduled for, or has already undergone, PCI.
Who cannot join
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis or currently active bleeding.
- Platelet count <100,000/mm at the time of enrollment.
- Hematocrit <25% at the time of enrollment.
- On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
Show all 18Show fewer
- Received fibrinolytics within the past 48 hours.
- Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if such a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
- Taking maintenance thienopyridine therapy in the previous 5 days.
- Known blood transfusion within the preceding 10 days.
- Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- Patients with known chronic liver disease.
- Age greater than 75 years
- Body weight less than 60 kg
- History of stroke or transient ischemic attack
- Surgery planned within 1 month
- Patient likely to require coronary artery bypass grafting
- Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
This is a genetic and platelet reactivity study of African-American versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The investigators aim is twofold: to describe differences in allele frequencies between African-Americans and Caucasians, and to explore associations of platelet reactivity and genetic polymorphisms in these two groups.
Read the detailed description
The investigators propose a pharmacogenetic cohort study of 100 African-American versus 100 Caucasian patients presenting with an acute coronary syndrome, receiving clopidogrel or prasugrel and undergoing PCI. The study will have four arms: African-American on clopidogrel; African-American on prasugrel; Caucasian on clopidogrel; and Caucasian on prasugrel. All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose, but before hospital discharge. All patients will be treated with aspirin 325 mg/day as well.
Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, et al) will be excluded from this study.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay
- Keywords
- Platelet reactivity, Genotyping
- 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.
Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assayOther
All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| African-American on clopidogrel | Not described Receives: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay | |
| African-American on prasugrel | Not described Receives: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay | |
| Caucasian on clopidogrel | Not described Receives: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay | |
| Caucasian on prasugrel | Not described Receives: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of CYP polymorphisms
CYP polymorphisms will be classified by their known effects upon enzyme function, using the consensus star-allele nomenclature. More specifically, patients will be classified as a "poor metabolizer" if they possess at least one CYP allele known to be associated with reduced function of that particular CYP enzyme. Allele frequencies will then be compared between African-american and Caucasian patients.
Measured: During hospital stay; average hospital stay is less than 48 hours
Secondary outcomes (1)
Platelet reactivity
The secondary exploratory objective is to assess for associations between "poor metabolizer" CYP genotypes and the levels of post-thienopyridine platelet reactivity.
Measured: During hospital stay; average hospital stay is less than 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408121
- Sponsor's protocol ID
- AA Genetic
- Acronym
- AA Genetic
- Status last verified
- Aug 2014
- First submitted
- 29 Jul 2011
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African-American Pharmacogenetics
- ClinicalTrials.gov ID
- NCT01408121
- Acronym / sponsor ID
- AA Genetic / AA Genetic
- Conditions
- Acute Coronary Syndrome
- Keywords
- Platelet reactivity, Genotyping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Aug 2011 (estimated)
- 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.
This is a genetic and platelet reactivity study of African-American versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The investigators aim is twofold: to describe differences in allele frequencies between African-Americans and Caucasians, and to explore associations of platelet reactivity and genetic polymorphisms in these two groups.
Detailed description
The investigators propose a pharmacogenetic cohort study of 100 African-American versus 100 Caucasian patients presenting with an acute coronary syndrome, receiving clopidogrel or prasugrel and undergoing PCI. The study will have four arms: African-American on clopidogrel; African-American on prasugrel; Caucasian on clopidogrel; and Caucasian on prasugrel. All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose, but before hospital discharge. All patients will be treated with aspirin 325 mg/day as well.
Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, et al) will be excluded from this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| African-American on clopidogrel | – | Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay |
| African-American on prasugrel | – | Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay |
| Caucasian on clopidogrel | – | Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay |
| Caucasian on prasugrel | – | Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African-american versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel.
Key inclusion criteria (9 listed)
- Patients age 18 or older, of both genders
- Presenting with an ACS, defined as at least two of the following:
- Self-reported African-american or Caucasian race
- No contraindications to prasugrel therapy.
- Patient is scheduled for, or has already undergone, PCI.
Key exclusion criteria (18 listed)
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis or currently active bleeding.
- Platelet count <100,000/mm at the time of enrollment.
- Hematocrit <25% at the time of enrollment.
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 |
|---|---|---|
| Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assayAll patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge. | Other | African-American on clopidogrel, African-American on prasugrel, Caucasian on clopidogrel, Caucasian on prasugrel |
Primary outcome
Distribution of CYP polymorphisms
Time frame: During hospital stay; average hospital stay is less than 48 hours
CYP polymorphisms will be classified by their known effects upon enzyme function, using the consensus star-allele nomenclature. More specifically, patients will be classified as a "poor metabolizer" if they possess at least one CYP allele known to be associated with reduced function of that particular CYP enzyme. Allele frequencies will then be compared between African-american and Caucasian patients.
1 secondary outcome
Platelet reactivity
Time frame: During hospital stay; average hospital stay is less than 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Related trials for Acute Coronary Syndrome
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Enrolling by invitationObservational study
Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI
Acute Coronary Syndrome
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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
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 Medstar Health Research Institute 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 18 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: status not confirmed, as of the sponsor's last update on 11 Aug 2014. 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?
Results are not available in the source record.
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?
Distribution of CYP polymorphisms (time frame: During hospital stay; average hospital stay is less than 48 hours). 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 11 Aug 2014.