Coronary Artery DiseasePhase 4STAMP-DESNCT02494284
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation
A Phase 4 study testing Clopidogrel and Aspirin plus clopidogrel in people with Coronary Artery Disease, run by CHEOL WHAN LEE, M.D., Ph.D at 12 sites in South Korea.
Trial summary
The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel and Aspirin plus clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 22 Dec 2015to 13 Feb 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 19 years of age
- Patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents
- Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Persistent thrombocytopenia (platelet count <100,000/µl)
- A known intolerance to a study drug (aspirin, clopidogrel)
- Patients requiring long-term oral anticoagulants or cilostazol
- Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure
- Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure
- Bare-metal stent implantation at the time of index procedure
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- Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- A diagnosis of cancer in the past 2 years or current treatment for the active cancer.
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
- Unwillingness or inability to comply with the procedures described in this protocol.
- Patients pregnant or breast-feeding or child-bearing potential.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Keimyung University Dongsan Medical Center
Daegu
Eulji University Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Inje University Ilsan Paik Hospital
Ilsan
Cheju Halla General Hospital
Jeju City
Asan Medical Center
Seoul
Kangbuk Samsung Medical Center
Seoul
Kyunghee University Medical Center
Seoul
SMA-SNU Boramae Medical Center
Seoul
The Catholic University of Korea St. Paul's Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel, Aspirin plus clopidogrel
- Keywords
- Coronary artery disease, Dual antiplatelet platelet therapy, Drug 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.
ClopidogrelDrug
6-month DAPT followed by clopidogrel monotherapy
Aspirin plus clopidogrelDrug
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Short term dual therapy | Experimental | Not described Receives: Drug: Clopidogrel |
| Long term dual therapy | Active comparator | Not described Receives: Drug: Aspirin plus clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically relevant bleeding
clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)
Measured: 18 months
Secondary outcomes (11)
Number of participants with death from cardiovascular cause
Measured: 18 months
Number of participants with myocardial infarction
Measured: 18 months
Number of participants with stroke
Measured: 18 months
Number of participants with stent thrombosis
Measured: 18 months
Number of participants with repeat revascularization
Measured: 18 months
Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5
Measured: 18 months
Number of participants with a composite of death from vascular causes or myocardial infarction
Measured: 18 months
Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis
Measured: 18 months
Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5
Measured: 18 months
Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)
Measured: 18 months
Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start22 Dec 2015
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Why it stopped: Slow enrollment
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Medtronic, Chong Kun Dang Pharmaceutical Corp.
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
- Investigators
- Seung-Jung Park, MD, Principal investigator, Asan Medical CenterCheol-Whan Lee, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494284
- Sponsor's protocol ID
- AMCCV2014-09
- Acronym
- STAMP-DES
- Status last verified
- Feb 2017
- First submitted
- 5 Jul 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
- ClinicalTrials.gov ID
- NCT02494284
- Acronym / sponsor ID
- STAMP-DES / AMCCV2014-09
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Dual antiplatelet platelet therapy, Drug eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 364 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.DUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Medtronic, Chong Kun Dang Pharmaceutical Corp.
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 10 Jul 2015 (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 is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short term dual therapy | Experimental | Drug: Clopidogrel |
| Long term dual therapy | Active comparator | Drug: Aspirin plus clopidogrel |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women at least 19 years of age
- Patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents
- Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (13 listed)
- Persistent thrombocytopenia (platelet count <100,000/µl)
- A known intolerance to a study drug (aspirin, clopidogrel)
- Patients requiring long-term oral anticoagulants or cilostazol
- Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure
- Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure
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 |
|---|---|---|
| Clopidogrel6-month DAPT followed by clopidogrel monotherapy | Drug | Short term dual therapy |
| Aspirin plus clopidogrelstandard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) | Drug | Long term dual therapy |
Primary outcome
Number of participants with clinically relevant bleeding
Time frame: 18 months
clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)
11 secondary outcomes
Number of participants with death from cardiovascular cause
Time frame: 18 months
Number of participants with myocardial infarction
Time frame: 18 months
Number of participants with stroke
Time frame: 18 months
Number of participants with stent thrombosis
Time frame: 18 months
Number of participants with repeat revascularization
Time frame: 18 months
Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5
Time frame: 18 months
Number of participants with a composite of death from vascular causes or myocardial infarction
Time frame: 18 months
Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis
Time frame: 18 months
Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5
Time frame: 18 months
Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)
Time frame: 18 months
Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Seung-Jung Park, MD principal investigator
Asan Medical Center
Cheol-Whan Lee, MD principal investigator
Asan Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Aspirin plus clopidogrel in people with Coronary Artery Disease, run by CHEOL WHAN LEE, M.D., Ph.D at 12 sites 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
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 was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Number of participants with clinically relevant bleeding (time frame: 18 months). 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 23 Feb 2017.