Acute Coronary SyndromeNCT01796873
Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention
An observational study of Acute Coronary Syndrome and Coronary Artery Disease, run by University of Arizona at 2 sites in United States.
Trial summary
Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to reduce the risk of having another heart attack by preventing platelets (blood cells that are important in forming blood clots) from sticking together and forming another clot. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Apr 2014
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females, age ≥ 45 years, with Acute Coronary Syndrome (ACS), undergone a percutaneous coronary intervention and currently treated with clopidogrel will be enrolled. The subjects' race and ethnicity will be self -reported and Hispanic ethnicity by self-report of having both parents of Hispanic/Latino descent.
Who may be able to join
- All females age 45 or greater, presenting to University of Arizona Medical Center South Campus or University Campus Cardiology service with a history of ACS
- Hispanics will be defined via self-reporting as having both parents of Latino descent
- Currently taking clopidogrel
Who cannot join
- Taking any of the following antiplatelet drugs:
- Prasugrel (Effient)
- Ticagrelor (Brilinta)
- Ticlopidine (Ticlid)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Arizona Medical Center South Campus
Tucson, Arizona, 85713
University of Arizona Medical Center University Campus
Tucson, Arizona, 85724
About this study
Official title: Clopidogrel Resistance and Platelet Reactivity in Hispanic Females Undergoing Percutaneous Coronary Intervention
Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to reduce the risk of having another heart attack by preventing platelets (blood cells that are important in forming blood clots) from sticking together and forming another clot. Platelet activity can be measured by a machine called VerifyNow.
The purpose of this study is to see whether Hispanic women and White non-Hispanic women have the same platelet response to a commonly used drug, Plavix (clopidogrel). Recent studies have shown that platelets may be more active in Hispanics, making it more difficult to prevent clots from forming, even when using Plavix. In addition, studies have shown that women may also have more active platelets than men. There have been no studies of Hispanic women and the effect of Plavix on platelet activity.
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Female, Hispanic, Percutaneous Coronary Intervention
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity measured by the VerifyNow P2Y12 Assay
Compare the Hispanic female platelet reactivity response to the Caucasian female platelet reactivity response in females currently taking clopidogrel.
Measured: At least 14 days following the ACS event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sasanka Jayasuriya, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796873
- Sponsor's protocol ID
- 12-0021-01
- Status last verified
- Jul 2013
- First submitted
- 19 Feb 2013
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Frelinger AL 3rd, Bhatt DL, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Lampa M, Brooks JK, Barnard MR, Michelson AD. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol. 2013 Feb 26;61(8):872-9. doi: 10.1016/j.jacc.2012.11.040. Epub 2013 Jan 16.
PubMed 23333143Wenaweser P, Daemen J, Zwahlen M, van Domburg R, Juni P, Vaina S, Hellige G, Tsuchida K, Morger C, Boersma E, Kukreja N, Meier B, Serruys PW, Windecker S. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol. 2008 Sep 30;52(14):1134-40. doi: 10.1016/j.jacc.2008.07.006.
PubMed 18804739Baber U. et al., Impact of Self-Reported Ethnicity on Response to Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2010;122:A20850
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel Resistance and Platelet Reactivity in Hispanic Females Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01796873
- Acronym / sponsor ID
- 12-0021-01
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Female, Hispanic, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Feb 2013 (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.
Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to reduce the risk of having another heart attack by preventing platelets (blood cells that are important in forming blood clots) from sticking together and forming another clot. Platelet activity can be measured by a machine called VerifyNow.
The purpose of this study is to see whether Hispanic women and White non-Hispanic women have the same platelet response to a commonly used drug, Plavix (clopidogrel). Recent studies have shown that platelets may be more active in Hispanics, making it more difficult to prevent clots from forming, even when using Plavix. In addition, studies have shown that women may also have more active platelets than men. There have been no studies of Hispanic women and the effect of Plavix on platelet activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females, age ≥ 45 years, with Acute Coronary Syndrome (ACS), undergone a percutaneous coronary intervention and currently treated with clopidogrel will be enrolled. The subjects' race and ethnicity will be self -reported and Hispanic ethnicity by self-report of having both parents of Hispanic/Latino descent.
Key inclusion criteria (3 listed)
- All females age 45 or greater, presenting to University of Arizona Medical Center South Campus or University Campus Cardiology service with a history of ACS
- Hispanics will be defined via self-reporting as having both parents of Latino descent
- Currently taking clopidogrel
Key exclusion criteria (4 listed)
- Taking any of the following antiplatelet drugs:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet Reactivity measured by the VerifyNow P2Y12 Assay
Time frame: At least 14 days following the ACS event
Compare the Hispanic female platelet reactivity response to the Caucasian female platelet reactivity response in females currently taking clopidogrel.
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 22 Aug 2024.
- Background: PubMed 23333143Frelinger AL 3rd, Bhatt DL, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Lampa M, Brooks JK, Barnard MR, Michelson AD. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol. 2013 Feb 26;61(8):872-9. doi: 10.1016/j.jacc.2012.11.040. Epub 2013 Jan 16.
- Background: PubMed 18804739Wenaweser P, Daemen J, Zwahlen M, van Domburg R, Juni P, Vaina S, Hellige G, Tsuchida K, Morger C, Boersma E, Kukreja N, Meier B, Serruys PW, Windecker S. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol. 2008 Sep 30;52(14):1134-40. doi: 10.1016/j.jacc.2008.07.006.
- BackgroundBaber U. et al., Impact of Self-Reported Ethnicity on Response to Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2010;122:A20850
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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.
Sasanka Jayasuriya, MD principal investigator
University of Arizona
2 sites 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 and Coronary Artery Disease, run by University of Arizona at 2 sites 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 3 inclusion and 4 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Platelet Reactivity measured by the VerifyNow P2Y12 Assay (time frame: At least 14 days following the ACS event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796873, which also lists 3 linked publications.
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 22 Aug 2024.