Increased Drug ResistanceVASPNCT01408927
Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population
An observational study of Increased Drug Resistance, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Increased Drug Resistance
- What is being tested?
- Thienopyridine resistance testing, Aspirin resistance testing and Genetic polymorphism assessment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 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: 1000 patients, male or female, older than 18 years of age, who are scheduled for or underwent percutaneous coronary intervention (PCI) or CABG and have been treated with a loading dose of a thienopyridine or on a maintenance dose of a thienopyridine.
Who may be able to join
- Patient >18 years old.
- PCI group only: Patient scheduled to undergo cardiac catheterization or underwent percutaneous coronary intervention (PCI), during hospital stay.
- CABG group only: Patient is scheduled to undergo, or has underwent, coronary artery bypass surgery with at least one saphenous vein graft.
- Treated with a loading dose of clopidogrel or prasugrel at least 6 hours prior to the blood draw, or on a maintenance dose of clopidogrel or prasugrel for a minimum of 5 days.
- Genetic testing subgroup only: Patient has undergone PCI (only), and has been treated with a thienopyridine as in 4.
Who cannot join
- Known allergies to aspirin, clopidogrel, or prasugrel;
- Use of a glycoprotein (GP) IIb/IIIa within 8 hours of the blood draw;
- Patient known to be pregnant or lactating;
- Patient with known history of bleeding diathesis or currently active bleeding;
- Platelet count <100,000/mm the day of the blood draw;
- Hematocrit <25% the day of the blood draw;
Show all 10Show fewer
- On warfarin therapy at the time of the blood draw;
- Known blood transfusion within the preceding 10 days of the blood draw;
- Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
- Any significant medical condition which 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, 1 recruiting
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ron Waksman, MD, 202-877-5975, ron.waksman@medstar.net
Ron Waksman, MD
About this study
Official title: Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population
The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).
Read the detailed description
This is a prospective cohort study of 1000 patients presenting to the Washington Hospital Center for percutaneous coronary intervention or coronary artery bypass surgery.
The aim of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population presenting for cardiac catheterization and undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Thienopyridine resistance will be measured by flow cytometry of the vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or the VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
A secondary objective of this study is to correlate a variety of genetic polymorphisms with levels of platelet reactivity.
- Conditions
- Increased Drug Resistance
- Being tested
- Thienopyridine resistance testing, Aspirin resistance testing, Genetic polymorphism assessment
- Keywords
- Thienopyridine resistance, Aspirin resistance, Platelet reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thienopyridine resistance testingOther
Thienopyridine resistance will be measured by flow cytometry of vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
Aspirin resistance testingOther
Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
Genetic polymorphism assessmentOther
The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence and degree of thienopyridine resistance
Thienopyridine resistance will be assessed by:
oThe VASP assay, which measures the platelet reactivity index; and/or oThe VerifyNow P2Y12 receptor inhibition assay, which measures P2Y12 reaction units (PRU); and/or oThe Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation; and/or oThe PlaCor PRT 7000 platelet reactivity assay
Measured: Duration of hospital stay; average hospital stay of less than 48 hours
Secondary outcomes (2)
The prevalence of aspirin resistance
The prevalence and degree of aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
Measured: Duration of hospital stay; average hospital stay of less than 48 hours
Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms
The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
Measured: Duration of hospital stay; average hospital stay of 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 startOct 2008
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Drug ResistanceStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408927
- Sponsor's protocol ID
- VASP
- Acronym
- VASP
- Status last verified
- Aug 2014
- First submitted
- 28 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
- Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population
- ClinicalTrials.gov ID
- NCT01408927
- Acronym / sponsor ID
- VASP / VASP
- Conditions
- Increased Drug Resistance
- Keywords
- Thienopyridine resistance, Aspirin resistance, Platelet reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 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.
The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).
Detailed description
This is a prospective cohort study of 1000 patients presenting to the Washington Hospital Center for percutaneous coronary intervention or coronary artery bypass surgery.
The aim of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population presenting for cardiac catheterization and undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Thienopyridine resistance will be measured by flow cytometry of the vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or the VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
A secondary objective of this study is to correlate a variety of genetic polymorphisms with levels of platelet reactivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 patients, male or female, older than 18 years of age, who are scheduled for or underwent percutaneous coronary intervention (PCI) or CABG and have been treated with a loading dose of a thienopyridine or on a maintenance dose of a thienopyridine.
Key inclusion criteria (5 listed)
- Patient >18 years old.
- PCI group only: Patient scheduled to undergo cardiac catheterization or underwent percutaneous coronary intervention (PCI), during hospital stay.
- CABG group only: Patient is scheduled to undergo, or has underwent, coronary artery bypass surgery with at least one saphenous vein graft.
- Treated with a loading dose of clopidogrel or prasugrel at least 6 hours prior to the blood draw, or on a maintenance dose of clopidogrel or prasugrel for a minimum of 5 days.
- Genetic testing subgroup only: Patient has undergone PCI (only), and has been treated with a thienopyridine as in 4.
Key exclusion criteria (10 listed)
- Known allergies to aspirin, clopidogrel, or prasugrel;
- Use of a glycoprotein (GP) IIb/IIIa within 8 hours of the blood draw;
- Patient known to be pregnant or lactating;
- Patient with known history of bleeding diathesis or currently active bleeding;
- Platelet count <100,000/mm the day of the blood draw;
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 |
|---|---|---|
| Thienopyridine resistance testingThienopyridine resistance will be measured by flow cytometry of vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay. | Other | – |
| Aspirin resistance testingAspirin resistance will be measured by the VerifyNow aspirin resistance assay. | Other | – |
| Genetic polymorphism assessmentThe presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system. | Other | – |
Primary outcome
The prevalence and degree of thienopyridine resistance
Time frame: Duration of hospital stay; average hospital stay of less than 48 hours
Thienopyridine resistance will be assessed by: oThe VASP assay, which measures the platelet reactivity index; and/or oThe VerifyNow P2Y12 receptor inhibition assay, which measures P2Y12 reaction units (PRU); and/or oThe Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation; and/or oThe PlaCor PRT 7000 platelet reactivity assay
2 secondary outcomes
The prevalence of aspirin resistance
Time frame: Duration of hospital stay; average hospital stay of less than 48 hours
Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms
Time frame: Duration of hospital stay; average hospital stay of 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.
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.
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 Increased Drug Resistance, 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 5 inclusion and 10 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?
Contact Ron Waksman, MD (202-877-5975, ron.waksman@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence and degree of thienopyridine resistance (time frame: Duration of hospital stay; average hospital stay of 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.