Coronary Artery DiseasePhase 4SEASIDENCT00963781
Scripps Evaluation of Antiplatelet Therapies for Intermediate Duration With the Endeavor Stent (Seaside)
A Phase 4 study testing Medtronic Endeavor Stent and Reduced duration (6 months) DAPT in people with Coronary Artery Disease and Coronary Thrombosis, run by Scripps Health at 1 site in United States.
Trial summary
Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat revascularization procedures, concerns regarding late stent thrombosis (ST) have led to recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine (clopidogrel or ticlopidine])… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Thrombosis
- What is being tested?
- Medtronic Endeavor Stent and Reduced duration (6 months) DAPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2013
- Phase
- Phase 4
- 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
Who may be able to join
- The patient is > 18 years of age.
- The patient must be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
- The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
- The patient has at least one lesion ≥50% diameter stenosis (de novo and/or restenotic, including in-stent bare metal stent restenosis) within a native coronary artery or bypass graft requiring percutaneous revascularization with stenting. (Note: Measurements may be made by careful visual estimate, on-line quantitative coronary angiography or intravascular ultrasound [IVUS].)
- The target lesion(s) reference vessel diameter is 2.5 to 4.0 mm
- The patient is an acceptable candidate for PTCA, stenting, and emergent coronary artery bypass grafting (CABG) surgery.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
- The patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the enrolling clinical site.
Who cannot join
- Planned treatment for any of the following patient and/or lesion characteristics:
- Unprotected left main disease
- Stage 4 chronic kidney disease, defined as creatinine clearance <30 mL/min and/or hemodialysis
- Planned 2-stent treatment of a bifurcation lesion
- Lesion length >30 mm
- Lesion containing angiographic evidence of thrombus
Show all 22Show fewer
- Treatment of 3 vessel coronary disease
- Severe left ventricular dysfunction (<25%)
- In-stent restenosis of previously placed DES
- A known hypersensitivity or contraindication to cobalt, nickel, chromium, molybdenum, polymer coatings (e.g., phosphorylcholine), or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative.
- A known hypersensitivity to clopidogrel, ticlopidine, aspirin, heparin or bivalirudin. Note: allergy to one thienopyridine type, but not another, does not constitute an exclusion.
- A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
- Evidence of recent/acute MI/acute coronary syndrome within preceding 6 months of the intended index procedure (defined as: dynamic ST-segment/T wave electrocardiographic changes and/or Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal, or troponin level elevated above the Institution's upper limit of normal).
- Treatment within the target vessel with any stent type within the previous 9 months
- Prior to procedure, intended use of DES other than Endeavor stent
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of bleeding diathesis or coagulopathy or patient will refuse blood transfusions.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
- Currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints
- Inability to comply with protocol required medication regimen (eg, [minimum] 6 month protocol-specified dual antiplatelet duration).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of Dual Antiplatelet Therapy Duration Following Treatment With the Medtronic Endeavor Zotarolimus-eluting Coronary Stent
Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat revascularization procedures, concerns regarding late stent thrombosis (ST) have led to recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine (clopidogrel or ticlopidine]) beyond that described in the product labeling. Specifically, an advisory has recommended at least 1 year DAPT following treatment with DES in patients without contraindications. However, this recommendation was largely empiric and not based on any trial showing reductions in ST with long-term DAPT, nor are potential safety differences between DES considered. Further, no study has examined the balance in potential efficacy with long-term DAPT relative to an increased bleeding risk.
A consistency across clinical trials involving the Endeavor DES has been very low rates of late myocardial infarction, cardiac death and ST. Unlike other DES, recent studies indicate that the Endeavor stent may permit more rapid and complete healing over stent struts in addition to restoring normal blood vessel function. Further, in patients treated with the Endeavor stent, long-term safety outcomes are similar through 3 years follow-up irrespective of whether patients were adherent to DAPT for durations of ≤ 6 months, 12 months or 24 months.
Read more
In this study, long-term safety and effectiveness will be examined for patients treated with the Endeavor stent and assigned to DAPT for reduced duration of 6 months. If the study demonstrates safety and efficacy, it could influence treatment guidelines in favor of an abbreviated duration of DAPT for patients treated with the Endeavor stent. This would mean that should a bleeding complication or need or surgery arise less than 12 months post-PCI, patients treated with the Endeavor stent could stop DAPT after 6 months with reasonable estimate of safety. Furthermore, it is possible that patients who are currently denied DES due to known need for elective surgery could be treated with the Endeavor stent in cases where surgery can be temporarily delayed. Finally, it could be an additional option for patients who forgo treatment with DES in favor of bare metal stent (BMS) out of fear of possible bleeding with long-term DAPT.
Finally, it is recognized that not all patients respond the same way to anti-platelet therapy. Recent studies have indicated that inherited genetic variations in the way the body metabolizes anti-platelet medications may be important determinants of responsiveness to thienopyridine therapy, and that such differences may also confer a higher likelihood of adverse outcome. Patients agreeing to the additional genetic sub-study will have a DNA sample taken at baseline to test for the presence of such genes related to antiplatelet therapy metabolism and effectiveness. The results of these tests could help the medical community to better understand individual variation in response to anti-platelet therapy and the role that genetics may play in determining the response. It is possible that the information gained could help physicians tailor DAPT on a patient by patient basis.
- Conditions
- Coronary Artery Disease, Coronary Thrombosis
- Being tested
- Medtronic Endeavor Stent, Reduced duration (6 months) DAPT
- Keywords
- Coronary Artery Disease, Drug-Eluting Stents, Coronary Thrombosis, Platelet Aggregation Inhibitors, Coronary Restenosis
- Medical subject headings
- Coronary Artery Disease, Coronary Thrombosis, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Endeavor StentDevice
The study population was to consist of 900 consecutive, eligible patients with ischemic heart disease scheduled to undergo elective percutaneous coronary revascularization and amenable to treatment with an Endeavor drug-eluting stent with reference vessel diameter between 2.5 and 4.0 mm. Patients will be assigned to 6 month duration of post-procedure thienopyridine treatment with indefinite aspirin (minimum 81 mg daily) according to protocol. Recruitment was terminated early due to difficulty recruiting patients and difficulty achieving patient compliance with the six month anti-platelet protocol.
Reduced duration (6 months) DAPTDrug
| Study group | Role | What they receive |
|---|---|---|
| Six months DAPT | Experimental | All patients will be assigned to 6 months of DAPT Receives: Device: Medtronic Endeavor Stent; Drug: Reduced duration (6 months) DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of all-cause death/myocardial infarction (MI)/stroke/definite and probable stent thrombosis (ST) at 1 year post-procedure (Hierarchal)
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 posted24 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2013
- Study completionAug 2013
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Paul S Teirstein, MD, Scripps Health
- Investigators
- David E Kandzari, MD, Principal investigator, Scripps ClinicPaul S. Teirstein, MD, Principal investigator, Scripps ClinicEric J. Topol, MD, Principal investigator, Scripps Clinic and Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963781
- Sponsor's protocol ID
- 09-5248
- Acronym
- SEASIDE
- Status last verified
- Oct 2020
- First submitted
- 20 Aug 2009
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Dual Antiplatelet Therapy Duration Following Treatment With the Medtronic Endeavor Zotarolimus-eluting Coronary Stent
- ClinicalTrials.gov ID
- NCT00963781
- Acronym / sponsor ID
- SEASIDE / 09-5248
- Conditions
- Coronary Artery Disease, Coronary Thrombosis
- Keywords
- Coronary Artery Disease, Drug-Eluting Stents, Coronary Thrombosis, Platelet Aggregation Inhibitors, Coronary Restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Aug 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Aug 2009 (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.
Despite the benefit of drug-eluting stents (DES) to reduce the need for repeat revascularization procedures, concerns regarding late stent thrombosis (ST) have led to recent guidelines advocating extended prescription of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine (clopidogrel or ticlopidine]) beyond that described in the product labeling. Specifically, an advisory has recommended at least 1 year DAPT following treatment with DES in patients without contraindications. However, this recommendation was largely empiric and not based on any trial showing reductions in ST with long-term DAPT, nor are potential safety differences between DES considered. Further, no study has examined the balance in potential efficacy with long-term DAPT relative to an increased bleeding risk.
A consistency across clinical trials involving the Endeavor DES has been very low rates of late myocardial infarction, cardiac death and ST. Unlike other DES, recent studies indicate that the Endeavor stent may permit more rapid and complete healing over stent struts in addition to restoring normal blood vessel function. Further, in patients treated with the Endeavor stent, long-term safety outcomes are similar through 3 years follow-up irrespective of whether patients were adherent to DAPT for durations of ≤ 6 months, 12 months or 24 months.
In this study, long-term safety and effectiveness will be examined for patients treated with the Endeavor stent and assigned to DAPT for reduced duration of 6 months. If the study demonstrates safety and efficacy, it could influence treatment guidelines in favor of an abbreviated duration of DAPT for patients treated with the Endeavor stent. This would mean that should a bleeding complication or need or surgery arise less than 12 months post-PCI, patients treated with the Endeavor stent could stop DAPT after 6 months with reasonable estimate of safety. Furthermore, it is possible that patients who are currently denied DES due to known need for elective surgery could be treated with the Endeavor stent in cases where surgery can be temporarily delayed. Finally, it could be an additional option for patients who forgo treatment with DES in favor of bare metal stent (BMS) out of fear of possible bleeding with long-term DAPT.
Finally, it is recognized that not all patients respond the same way to anti-platelet therapy. Recent studies have indicated that inherited genetic variations in the way the body metabolizes anti-platelet medications may be important determinants of responsiveness to thienopyridine therapy, and that such differences may also confer a higher likelihood of adverse outcome. Patients agreeing to the additional genetic sub-study will have a DNA sample taken at baseline to test for the presence of such genes related to antiplatelet therapy metabolism and effectiveness. The results of these tests could help the medical community to better understand individual variation in response to anti-platelet therapy and the role that genetics may play in determining the response. It is possible that the information gained could help physicians tailor DAPT on a patient by patient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Six months DAPT | Experimental | Device: Medtronic Endeavor Stent, Drug: Reduced duration (6 months) DAPTAll patients will be assigned to 6 months of DAPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient is > 18 years of age.
- The patient must be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
- The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
- The patient has at least one lesion ≥50% diameter stenosis (de novo and/or restenotic, including in-stent bare metal stent restenosis) within a native coronary artery or bypass graft requiring percutaneous revascularization with stenting. (Note: Measurements may be made by careful visual estimate, on-line quantitative coronary angiography or intravascular ultrasound [IVUS].)
- The target lesion(s) reference vessel diameter is 2.5 to 4.0 mm
Key exclusion criteria (22 listed)
- Planned treatment for any of the following patient and/or lesion characteristics:
- A known hypersensitivity or contraindication to cobalt, nickel, chromium, molybdenum, polymer coatings (e.g., phosphorylcholine), or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative.
- A known hypersensitivity to clopidogrel, ticlopidine, aspirin, heparin or bivalirudin. Note: allergy to one thienopyridine type, but not another, does not constitute an exclusion.
- A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
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 |
|---|---|---|
| Medtronic Endeavor StentThe study population was to consist of 900 consecutive, eligible patients with ischemic heart disease scheduled to undergo elective percutaneous coronary revascularization and amenable to treatment with an Endeavor drug-eluting stent with reference vessel diameter between 2.5 and 4.0 mm. Patients will be assigned to 6 month duration of post-procedure thienopyridine treatment with indefinite aspirin (minimum 81 mg daily) according to protocol. Recruitment was terminated early due to difficulty recruiting patients and difficulty achieving patient compliance with the six month anti-platelet protocol. | Device | Six months DAPT |
| Reduced duration (6 months) DAPT | Drug | Six months DAPT |
Primary outcome
Composite endpoint of all-cause death/myocardial infarction (MI)/stroke/definite and probable stent thrombosis (ST) at 1 year post-procedure (Hierarchal)
Time frame: 1 year
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 20 Oct 2020.
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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.
David E Kandzari, MD principal investigator
Scripps Clinic
Paul S. Teirstein, MD principal investigator
Scripps Clinic
Eric J. Topol, MD principal investigator
Scripps Clinic and Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medtronic Endeavor Stent and Reduced duration (6 months) DAPT in people with Coronary Artery Disease and Coronary Thrombosis, run by Scripps Health 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 8 inclusion and 22 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 20 Oct 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite endpoint of all-cause death/myocardial infarction (MI)/stroke/definite and probable stent thrombosis (ST) at 1 year post-procedure (Hierarchal) (time frame: 1 year). 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 20 Oct 2020.