Coronary Artery DiseaseDATENCT00418860
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent
A study testing Aspirin, Clopidogrel in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aspirin, Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Apr 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with clinically significant de novo coronary artery disease
- Stenting only with Endeavor® stents
- The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.
Who cannot join
- Cardiogenic shock
- ST-elevation myocardial infarction within 48 hours of symptom onset
- Prior implantation of drug-eluting stents
- Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
- Stenting both branch of bifurcation lesion
- Left main trunk lesion
Show all 15Show fewer
- Graft vessels
- Patients who have to receive clopidogrel due to other conditions
- Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
- Patient with chronic renal failure (S-Cr > 2.0 mg/dl)
- Hypersensitivity to clopidogrel or aspirin
- Expectant survival less than 1 year
- Women who plan to become pregnant
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)
The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.
- Conditions
- Coronary Artery Disease
- Being tested
- Aspirin, Clopidogrel
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Stent thrombosis, Zotarolimus-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin, ClopidogrelDrug
Also called plavix
Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Aspirin, Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard
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 posted5 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionApr 2009
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 Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Hyeon-Cheol Gwon, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418860
- Sponsor's protocol ID
- 2006-09-025
- Acronym
- DATE
- Status last verified
- Aug 2011
- First submitted
- 3 Jan 2007
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)
- ClinicalTrials.gov ID
- NCT00418860
- Acronym / sponsor ID
- DATE / 2006-09-025
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Stent thrombosis, Zotarolimus-eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Jan 2007 (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 purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Aspirin, Clopidogrel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinically significant de novo coronary artery disease
- Stenting only with Endeavor® stents
- The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.
Key exclusion criteria (15 listed)
- Cardiogenic shock
- ST-elevation myocardial infarction within 48 hours of symptom onset
- Prior implantation of drug-eluting stents
- Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
- Stenting both branch of bifurcation lesion
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 |
|---|---|---|
| Aspirin, ClopidogrelAlso: plavixAspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure | Drug | A |
Primary outcome
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard
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 11 Aug 2011.
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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.
Hyeon-Cheol Gwon, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Clopidogrel in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
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 15 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 11 Aug 2011. 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 South Korea. 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?
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard (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 11 Aug 2011.