Coronary Artery DiseaseARIVE-PCINCT01278043
Antiplatelet Response, Interval Variability & Events in Percutaneous Coronary Intervention (ARIVE-PCI) Registry
An observational study of Coronary Artery Disease, run by University of Chicago at 1 site in United States.
Trial summary
Subjects in this study have recently had or are scheduled for a percutaneous coronary intervention (PCI) as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2010to 5 Sep 2024
- 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: 100 consecutive patients undergoing PCI at a single medical center will be enrolled in this prospective, open cohort study.
Who may be able to join
- Written informed consent for study participation will be obtained following performance of clinically-indicated PCI
- 18 years old and up
- Subjects must have received an oral load of clopidogrel (600 mg total) and aspirin (325 mg if aspirin naïve or minimum 81 mg if on therapy for ≥ 5 days) over the 24 hours preceding enrollment in order to be eligible.
Who cannot join
- Patients who are unable or unwilling to provide written informed consent or an accurate medical history,
- patients unwilling to participate in follow-up,
- incarcerated or pregnant patients and patients under 18 years of age will be excluded.
- Additionally patients within 24 hours of discontinuation of eptifibatide or tirofiban infusion or within 2 weeks of abciximab infusion,
- patients on antiplatelet monotherapy and patients currently on cilostazol or dipyridomole will be excluded as will those likely to discontinue dual antiplatelet therapy during the 6-month follow up.
- Patients with active bleeding or recent cerebrovascular accident (CVA, "stroke") (≤1 month) at the time of PCI will be excluded, however patients with a history of CVA, bleeding, anemia or thrombocytopenia are eligible providing the clinically-determined careplan includes long-term dual antiplatelet therapy (DAPT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Predictors and Impact of Response Variability to Oral Dual Antiplatelet Therapy, as Measured by Point-of-care Platelet Aggregometry, Following Percutaneous Coronary Intervention
Subjects in this study have recently had or are scheduled for a percutaneous coronary intervention (PCI) as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.
One complication that can occur after a PCI procedure is blood clotting and narrowing of the artery in the area that was treated. This can result in a decrease in the blood flow to the heart. To avoid this complication, patients are given antiplatelet or "blood-thinning" drugs such as aspirin and clopidogrel as part of their routine care after this procedure.
For this research study, the investigators would like to take blood samples from subjects at 3 different time points while they are taking these antiplatelet drugs. The investigators will study the subjects' blood and medical history to help us further our understanding of how these drugs respond in individuals and in certain patient populations. Everyone responds a little differently to medications due to many reasons including our genetic make-up. Genes are passed down from our parents and determine our physical appearance such as the color of our hair and eyes. Differences in our genes may also help explain why some drugs work in some people, but not in others. By studying subjects' blood, medical history, genetic make-up and by recording how the subjects' blood responds over the course of their treatment, the investigators hope to learn more about how our bodies respond when taking these drugs. Additionally, the investigators hope to find better ways to predict who will respond more effectively to these drugs and better ways to monitor how these drugs are working in patients' bodies over time after PCI procedures.
- Conditions
- Coronary Artery Disease
- Keywords
- Antiplatelet, Percutaneous Coronary Intervention, Coronary artery disease, Antiplatelet Response, Interval Variability & Events in Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is occurrence of significant interval thienopyridine response variability and/or inhibition of platelet aggregation (IPA)) measured at study entry vs. 1 week vs. 1 month following oral thienopyridine load.
Measured: 1 month
The co-primary endpoint is occurrence of absolute thienopyridine hyporesponse at any of the specified timepoints.
Measured: 2 years
Secondary outcomes (3)
The secondary endpoint of the study explores the relationship between CYP 2C19 genotypes (ultra-rapid and extensive metabolizers vs. intermediate and poor metabolizers) and thienopyridine response / response variability.
Measured: 2 years
Exploratory analyses will assess correlation between point-of-care platelet aggregometry (VerifyNow) and laboratory-based assessment of platelet function via Light Transmittance Aggregometry (LTA).
Measured: 2 years
Additional analysis will explore the correlation between antiplatelet response to aspirin (ASA) and thienopyridines with incident major adverse cardiac events (MACE) and bleeding events during a 6 month follow-up period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study start1 May 2010
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
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 University of ChicagoThe 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
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandeep Nathan, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278043
- Sponsor's protocol ID
- 10-222-A
- Acronym
- ARIVE-PCI
- Status last verified
- Sep 2024
- First submitted
- 10 Jan 2011
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Predictors and Impact of Response Variability to Oral Dual Antiplatelet Therapy, as Measured by Point-of-care Platelet Aggregometry, Following Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01278043
- Acronym / sponsor ID
- ARIVE-PCI / 10-222-A
- Conditions
- Coronary Artery Disease
- Keywords
- Antiplatelet, Percutaneous Coronary Intervention, Coronary artery disease, Antiplatelet Response, Interval Variability & Events in Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 17 Jan 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.
Subjects in this study have recently had or are scheduled for a percutaneous coronary intervention (PCI) as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.
One complication that can occur after a PCI procedure is blood clotting and narrowing of the artery in the area that was treated. This can result in a decrease in the blood flow to the heart. To avoid this complication, patients are given antiplatelet or "blood-thinning" drugs such as aspirin and clopidogrel as part of their routine care after this procedure.
For this research study, the investigators would like to take blood samples from subjects at 3 different time points while they are taking these antiplatelet drugs. The investigators will study the subjects' blood and medical history to help us further our understanding of how these drugs respond in individuals and in certain patient populations. Everyone responds a little differently to medications due to many reasons including our genetic make-up. Genes are passed down from our parents and determine our physical appearance such as the color of our hair and eyes. Differences in our genes may also help explain why some drugs work in some people, but not in others. By studying subjects' blood, medical history, genetic make-up and by recording how the subjects' blood responds over the course of their treatment, the investigators hope to learn more about how our bodies respond when taking these drugs. Additionally, the investigators hope to find better ways to predict who will respond more effectively to these drugs and better ways to monitor how these drugs are working in patients' bodies over time after PCI procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 consecutive patients undergoing PCI at a single medical center will be enrolled in this prospective, open cohort study.
Key inclusion criteria (3 listed)
- Written informed consent for study participation will be obtained following performance of clinically-indicated PCI
- 18 years old and up
- Subjects must have received an oral load of clopidogrel (600 mg total) and aspirin (325 mg if aspirin naïve or minimum 81 mg if on therapy for ≥ 5 days) over the 24 hours preceding enrollment in order to be eligible.
Key exclusion criteria (6 listed)
- Patients who are unable or unwilling to provide written informed consent or an accurate medical history,
- patients unwilling to participate in follow-up,
- incarcerated or pregnant patients and patients under 18 years of age will be excluded.
- Additionally patients within 24 hours of discontinuation of eptifibatide or tirofiban infusion or within 2 weeks of abciximab infusion,
- patients on antiplatelet monotherapy and patients currently on cilostazol or dipyridomole will be excluded as will those likely to discontinue dual antiplatelet therapy during the 6-month follow up.
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
The primary endpoint of the study is occurrence of significant interval thienopyridine response variability and/or inhibition of platelet aggregation (IPA)) measured at study entry vs. 1 week vs. 1 month following oral thienopyridine load.
Time frame: 1 month
The co-primary endpoint is occurrence of absolute thienopyridine hyporesponse at any of the specified timepoints.
Time frame: 2 years
3 secondary outcomes
The secondary endpoint of the study explores the relationship between CYP 2C19 genotypes (ultra-rapid and extensive metabolizers vs. intermediate and poor metabolizers) and thienopyridine response / response variability.
Time frame: 2 years
Exploratory analyses will assess correlation between point-of-care platelet aggregometry (VerifyNow) and laboratory-based assessment of platelet function via Light Transmittance Aggregometry (LTA).
Time frame: 2 years
Additional analysis will explore the correlation between antiplatelet response to aspirin (ASA) and thienopyridines with incident major adverse cardiac events (MACE) and bleeding events during a 6 month follow-up period.
Time frame: 6 months
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 19 Sep 2024.
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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.
Sandeep Nathan, MD principal investigator
University of Chicago
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 University of Chicago 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 3 inclusion and 6 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 19 Sep 2024. 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?
The primary endpoint of the study is occurrence of significant interval thienopyridine response variability and/or inhibition of platelet aggregation (IPA)) measured at study entry vs. 1 week vs. 1 month following oral thienopyridine load. (time frame: 1 month). The study lists 2 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 19 Sep 2024.