Coronary Artery DiseaseFDI-DAPT-ZESNCT01219894
Intravascular Optical Coherence Tomography Imaging - Length of Anti-Platelet Therapy After Drug Eluting Stent Placement
An observational study of Coronary Artery Disease, run by Emory University.
Trial summary
Patients who receive drug-coated stents (as opposed to the less frequently used bare metal stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or Ticlid for one year. These guidelines apply to all patients with drug-coated stents, regardless of the type of stent they received. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2010
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with a single DES (EndeavorTM, zotarolimus, Medtronic Vascular) will be enrolled in this study.
Who may be able to join
- Any patient requiring percutaneous coronary intervention and meeting criteria (as determined by the performing physician) for Endeavor Drug Eluting Stent Placement
Who cannot join
- Patients requiring >1 stent per treated lesion
- ST segment elevation MI (STEMI)
- inability to comply with study follow-up including 12 months of DAPT
- current or planned pregnancy (for women of childbearing age)
About this study
Official title: Frequency Domain Imaging to Determine Stent Strut Coverage and Duration of Anti-Platelet Treatment After Endeavor Stent Placement
Patients who receive drug-coated stents (as opposed to the less frequently used bare metal stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or Ticlid for one year. These guidelines apply to all patients with drug-coated stents, regardless of the type of stent they received. The purpose of these medications is to prevent a clot at the stent site when there is poor healing of artery tissues over the stent. A clot is a serious concern because it can suddenly block blood flow to the heart and cause a heart attack. These medications have been proven to be helpful in stent patients, but they do have risks. The common side-effects are related to bleeding which in a few patients can be serious. A patient may be at risk for forming a clot if they must put these medications on hold for a surgical procedure to reduce the risk of bleeding. Plavix and Effient are also expensive for patients who are underinsured or uninsured. There is interest is finding a way to show that a patient's stent has healed properly before 12 months and that they can safely stop these medications early.
This study is looking at a way to determine if patients who receive the Endeavor drug-coated stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead of 12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor stent after 3 months.
A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to look at how much a stent has healed. It allows imaging inside a heart artery and the ability to see the healing of tissues over the stent.
Read the detailed description
There is a need to find a personalized approach to prescribing dual anti-platelet therapy after a stent is placed in a coronary artery. Stenting involves inserting and expanding a metal tube-shaped device in a heart artery where a blockage is limiting blood flow to the heart muscle. This device stays in the artery permanently and the body's tissues grow over it over time.
Patients in the study will have Optical Coherence Tomography (OCT) imaging done before stent placement and again 3 months later in a follow-up angiography. Patients with sufficient stent healing at 3 months will stop taking Plavix. Patients who have poor stent healing at 3 months will have to continue Plavix through 12 months. Patients will be called once a month during the first year to see how they are doing and if they are taking their prescribed medicines.
Other diagnostic methods that are used when patients have suspected heart blockages include intravascular ultrasound (a device on a catheter that allows ultrasound imaging inside a vessel), fractional flow reserve (a measurement of blood flow to determine if a blockages is serious enough to need treatment), angiography (injection of dye into the arteries to look for narrowing or blockages). These methods are used to look at the severity of heart blockages once a patient already has signs and symptoms. They are not appropriate devices for seeing if a patient's previous stent has healed properly after a certain period of time.
The long-term effectiveness of stenting procedures to treat symptomatic coronary artery disease is limited by the need to take dual anti-platelet therapy (DAPT) with aspirin and plavix to prevent complications related to clot formation within these devices due to incomplete healing of the stented segment. While anti-platelet pharmacologic therapy can minimize this risk, it is associated with an increased risk of serious bleeding events. Currently all patients receiving drug eluting stents (DES) are advised to take plavix for twelve months although a personalized approach for determining the appropriate duration of anti-platelet therapy on a patient by patient basis would reduce both thrombosis and bleeding, thereby improving the long-term safety of coronary revascularization procedures. Optical coherence tomography (OCT) is a new high resolution imaging modality with the potential to discern stent strut healing at follow-up and thus allow for individual tailoring of anti-platelet regimens. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (ZES or Endeavor) has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies and it is very likely earlier discontinuation of anti-platelet therapy is safe. In this trial, patients undergoing ZES placement for symptomatic CAD will undergo 3 months follow-up OCT imaging to determine stent strut healing. Patients demonstrating complete healing will be withdrawn from plavix (with aspirin continued) while those with evidence of incomplete healing will be continued on DAPT for another 9 months. All patients will be followed clinically for another 9 months and intercurrent adverse events recorded. In the end, this research will establish OCT determined stent healing as a surrogate measure for determining optimal anti-platelet therapy following DES implantation.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Disease, Stent, Healing, Anti-platelet therapy
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RUTTS Score <30% | Patients with evidence of complete healing of stent at 3 months | |
| RUTTS<30% | Group with evidence of incomplete healing of the stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30% of the target stent as determined by OCT pullback of the target stent
Primary Endpoint: The primary endpoint of this trial will be the frequency of near complete healing 3 months after Endeavor placement defined as a Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30%.
Measured: 3 months
Secondary outcomes (4)
death
Occurrence of events after 3-month follow-up in the group with OCT guided early discontinuation of DAPT versus those adhering to standard of care (i.e. 12 months of DAPT). Events will be defined as death, stent thrombosis (Academic Research Consortium definition), myocardial infarction (defined as any evidence of troponin elevation above the upper limit of normal), and bleeding (TIMI Bleeding Classification (table 1)). We will also examine the relationship between underlying plaque morphology and 3 month follow-up OCT determined strut coverage.
Measured: 1 year
Stent Thrombosis
As defined by the Academic Research Consortium definition.
Measured: 1 year
myocardial infarction
Defined as any troponin elevation above the upper limit of normal
Measured: 1 year
Bleeding
As defined by the TIMI Bleeding Classification.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Number of patients to meet individual IDE requirements was not obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Vascular, Light Lab Imaging, Inc., Abbott Medical Devices
- Responsible party
- Principal investigator, Aloke V. Finn, Emory University
- Investigators
- Aloke Finn, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219894
- Sponsor's protocol ID
- IRB00045456
- Acronym
- FDI-DAPT-ZES
- Status last verified
- Nov 2013
- First submitted
- 8 Oct 2010
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
PubMed 17438147Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.
PubMed 20129551
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Domain Imaging to Determine Stent Strut Coverage and Duration of Anti-Platelet Treatment After Endeavor Stent Placement
- ClinicalTrials.gov ID
- NCT01219894
- Acronym / sponsor ID
- FDI-DAPT-ZES / IRB00045456
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Disease, Stent, Healing, Anti-platelet therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Number of patients to meet individual IDE requirements was not obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Medtronic Vascular, Light Lab Imaging, Inc., Abbott Medical Devices
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Oct 2010 (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.
Patients who receive drug-coated stents (as opposed to the less frequently used bare metal stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or Ticlid for one year. These guidelines apply to all patients with drug-coated stents, regardless of the type of stent they received. The purpose of these medications is to prevent a clot at the stent site when there is poor healing of artery tissues over the stent. A clot is a serious concern because it can suddenly block blood flow to the heart and cause a heart attack. These medications have been proven to be helpful in stent patients, but they do have risks. The common side-effects are related to bleeding which in a few patients can be serious. A patient may be at risk for forming a clot if they must put these medications on hold for a surgical procedure to reduce the risk of bleeding. Plavix and Effient are also expensive for patients who are underinsured or uninsured. There is interest is finding a way to show that a patient's stent has healed properly before 12 months and that they can safely stop these medications early.
This study is looking at a way to determine if patients who receive the Endeavor drug-coated stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead of 12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor stent after 3 months.
A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to look at how much a stent has healed. It allows imaging inside a heart artery and the ability to see the healing of tissues over the stent.
Detailed description
There is a need to find a personalized approach to prescribing dual anti-platelet therapy after a stent is placed in a coronary artery. Stenting involves inserting and expanding a metal tube-shaped device in a heart artery where a blockage is limiting blood flow to the heart muscle. This device stays in the artery permanently and the body's tissues grow over it over time.
Patients in the study will have Optical Coherence Tomography (OCT) imaging done before stent placement and again 3 months later in a follow-up angiography. Patients with sufficient stent healing at 3 months will stop taking Plavix. Patients who have poor stent healing at 3 months will have to continue Plavix through 12 months. Patients will be called once a month during the first year to see how they are doing and if they are taking their prescribed medicines.
Other diagnostic methods that are used when patients have suspected heart blockages include intravascular ultrasound (a device on a catheter that allows ultrasound imaging inside a vessel), fractional flow reserve (a measurement of blood flow to determine if a blockages is serious enough to need treatment), angiography (injection of dye into the arteries to look for narrowing or blockages). These methods are used to look at the severity of heart blockages once a patient already has signs and symptoms. They are not appropriate devices for seeing if a patient's previous stent has healed properly after a certain period of time.
The long-term effectiveness of stenting procedures to treat symptomatic coronary artery disease is limited by the need to take dual anti-platelet therapy (DAPT) with aspirin and plavix to prevent complications related to clot formation within these devices due to incomplete healing of the stented segment. While anti-platelet pharmacologic therapy can minimize this risk, it is associated with an increased risk of serious bleeding events. Currently all patients receiving drug eluting stents (DES) are advised to take plavix for twelve months although a personalized approach for determining the appropriate duration of anti-platelet therapy on a patient by patient basis would reduce both thrombosis and bleeding, thereby improving the long-term safety of coronary revascularization procedures. Optical coherence tomography (OCT) is a new high resolution imaging modality with the potential to discern stent strut healing at follow-up and thus allow for individual tailoring of anti-platelet regimens. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (ZES or Endeavor) has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies and it is very likely earlier discontinuation of anti-platelet therapy is safe. In this trial, patients undergoing ZES placement for symptomatic CAD will undergo 3 months follow-up OCT imaging to determine stent strut healing. Patients demonstrating complete healing will be withdrawn from plavix (with aspirin continued) while those with evidence of incomplete healing will be continued on DAPT for another 9 months. All patients will be followed clinically for another 9 months and intercurrent adverse events recorded. In the end, this research will establish OCT determined stent healing as a surrogate measure for determining optimal anti-platelet therapy following DES implantation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTTS Score <30% | – | –Patients with evidence of complete healing of stent at 3 months |
| RUTTS<30% | – | –Group with evidence of incomplete healing of the stent |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with a single DES (EndeavorTM, zotarolimus, Medtronic Vascular) will be enrolled in this study.
Key inclusion criteria (1 listed)
- Any patient requiring percutaneous coronary intervention and meeting criteria (as determined by the performing physician) for Endeavor Drug Eluting Stent Placement
Key exclusion criteria (4 listed)
- Patients requiring >1 stent per treated lesion
- ST segment elevation MI (STEMI)
- inability to comply with study follow-up including 12 months of DAPT
- current or planned pregnancy (for women of childbearing age)
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
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30% of the target stent as determined by OCT pullback of the target stent
Time frame: 3 months
Primary Endpoint: The primary endpoint of this trial will be the frequency of near complete healing 3 months after Endeavor placement defined as a Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30%.
4 secondary outcomes
death
Time frame: 1 year
Stent Thrombosis
Time frame: 1 year
myocardial infarction
Time frame: 1 year
Bleeding
Time frame: 1 year
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 20 Nov 2013.
- Background: PubMed 17438147Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
- Background: PubMed 20129551Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.
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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.
Aloke Finn, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Emory University.
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 1 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: withdrawn, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30% of the target stent as determined by OCT pullback of the target stent (time frame: 3 months). 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 NCT01219894, which also lists 2 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 20 Nov 2013.