Coronary Artery DiseasePhase 4STOPDAPTNCT01659034
Short and Optimal Duration of Dual Antiplatelet Therapy Study
A Phase 4 study testing Thienopyridine for 3 months in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Thienopyridine for 3 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,525 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who received PCI using everolimus-eluting cobalt-chromium stents
Who cannot join
- Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Kyoto University Hospital
Kyoto, Kyoto, 606-8507
About this study
The purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.
Read the detailed description
"Thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (BMS). On the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: DAPT) for more than 1 year after drug-eluting stent (DES) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. In the RESET study, which was carried out in clinical practice in Japan, DAPT was performed for at least 1 year in 90% of the patients. However, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. These results suggest that the optimal duration of DAPT after DES implantation may be shorter than 6 months.
With respect to Everolimus-eluting stent (EES), which is the most widely used DES in Japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation DES and with BMS in large-scale observational study and randomized comparative studies and their meta-analyses.
Considering that long-term DAPT obviously increases hemorrhagic complications compared to Aspirin monotherapy, it is desirable to reduce the duration of DAPT as far as possible, if long-term DAPT is not effective in inhibiting the incidence of serious cardiovascular events. Moreover, long-term DAPT enormously increases medical expenses. In this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an EES (XIENCE Prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.
- Conditions
- Coronary Artery Disease
- Being tested
- Thienopyridine for 3 months
- Keywords
- Anti-platelet therapy
- 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.
Thienopyridine for 3 monthsDrug
| Study group | Role | What they receive |
|---|---|---|
| Thienopyridine | Experimental | Thienopyridine treatment for 3 months after implantation of everolimus-eluting Stents Receives: Drug: Thienopyridine for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular and bleeding events
Composite of cardiovascular death, myocardial infarction, stroke (ischemic and hemorrhagic), stent thrombosis (definite stent thrombosis not resulting in myocardial infarction), and major bleeding (TIMI Major/Minor) Cardiovascular death, myocardial infarction and stent thrombosis are defined according to the definition in the Academic Research Consortium (ARC). Stroke is defined as ischemic or hemorrhagic stroke with symptoms lasting > 24 hour. Major bleeding is defined according to the definition in the Thrombosis in Myocardial Infarction (TIMI).
Measured: 1-year
Secondary outcomes (18)
Cardiovascular death/MI/stroke/definite ST
Composite of cardiovascular death, myocardial infarction, stroke, and definite stent thrombosis
Measured: 1-year
Major bleeding (TIMI Major/Minor)
Major bleeding (TIMI Major/Minor)
Measured: 1-year
Death/MI
Composite of all-cause death and myocardial infarction
Measured: 1-year
All-cause death
All-cause death
Measured: 1-year
Cardiovascular death/MI
Composite of cardiovascular death and myocardial infarction
Measured: 1-year
Cardiovascular death
Cardiovascular death
Measured: 1-year
MI
Myocardial infarction
Measured: 1-year
Stroke
Both ischemic and hemorrhagic stroke excluding transient ischemic attack
Measured: 1-year
Stent Thrombosis
Stent thrombosis according to Academic Research Consortium classification
Measured: 1-year
Target Lesion Failure
Composite of cardiovascular death, myocardial infarction due to target vessel, and target lesion revascularization
Measured: 1-year
Target Vessel Failure
Composite of cardiovascular death, myocardial infarction, and target vessel revascularization
Measured: 1-year
Major Adverse Cardiac Events
Composite of cardiovascular death, myocardial infarction, and clinically-driven target lesion revascularization
Measured: 1-year
Target Lesion Revascularization
Target lesion revascularization
Measured: 1-year
Clinically-driven Target Lesion Revascularization
Clinically-driven Target Lesion Revascularization
Measured: 1-year
Non Target Lesion Revascularization
Revascularization for non-target vessel or target vessel but target lesion
Measured: 1-year
CABG
Coronary artery bypass graft
Measured: 1-year
Target Vessel Revascularization
Target vessel revascularization
Measured: 1-year
Any bleeding
Any bleeding complications
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 posted7 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionDec 2014
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
- 1,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, PhD, Principal investigator, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659034
- Sponsor's protocol ID
- C-645
- Acronym
- STOPDAPT
- Status last verified
- Dec 2015
- First submitted
- 30 Jul 2012
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Optimal Duration of Dual Antiplatelet Therapy Study
- ClinicalTrials.gov ID
- NCT01659034
- Acronym / sponsor ID
- STOPDAPT / C-645
- Conditions
- Coronary Artery Disease
- Keywords
- Anti-platelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,525 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Aug 2012 (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 evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.
Detailed description
"Thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (BMS). On the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: DAPT) for more than 1 year after drug-eluting stent (DES) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. In the RESET study, which was carried out in clinical practice in Japan, DAPT was performed for at least 1 year in 90% of the patients. However, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. These results suggest that the optimal duration of DAPT after DES implantation may be shorter than 6 months.
With respect to Everolimus-eluting stent (EES), which is the most widely used DES in Japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation DES and with BMS in large-scale observational study and randomized comparative studies and their meta-analyses.
Considering that long-term DAPT obviously increases hemorrhagic complications compared to Aspirin monotherapy, it is desirable to reduce the duration of DAPT as far as possible, if long-term DAPT is not effective in inhibiting the incidence of serious cardiovascular events. Moreover, long-term DAPT enormously increases medical expenses. In this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an EES (XIENCE Prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thienopyridine | Experimental | Drug: Thienopyridine for 3 monthsThienopyridine treatment for 3 months after implantation of everolimus-eluting Stents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who received PCI using everolimus-eluting cobalt-chromium stents
Key exclusion criteria (1 listed)
- Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents
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 for 3 months | Drug | Thienopyridine |
Primary outcome
Major cardiovascular and bleeding events
Time frame: 1-year
Composite of cardiovascular death, myocardial infarction, stroke (ischemic and hemorrhagic), stent thrombosis (definite stent thrombosis not resulting in myocardial infarction), and major bleeding (TIMI Major/Minor) Cardiovascular death, myocardial infarction and stent thrombosis are defined according to the definition in the Academic Research Consortium (ARC). Stroke is defined as ischemic or hemorrhagic stroke with symptoms lasting > 24 hour. Major bleeding is defined according to the definition in the Thrombosis in Myocardial Infarction (TIMI).
18 secondary outcomes
Cardiovascular death/MI/stroke/definite ST
Time frame: 1-year
Major bleeding (TIMI Major/Minor)
Time frame: 1-year
Death/MI
Time frame: 1-year
All-cause death
Time frame: 1-year
Cardiovascular death/MI
Time frame: 1-year
Cardiovascular death
Time frame: 1-year
MI
Time frame: 1-year
Stroke
Time frame: 1-year
Stent Thrombosis
Time frame: 1-year
Target Lesion Failure
Time frame: 1-year
Target Vessel Failure
Time frame: 1-year
Major Adverse Cardiac Events
Time frame: 1-year
Target Lesion Revascularization
Time frame: 1-year
Clinically-driven Target Lesion Revascularization
Time frame: 1-year
Non Target Lesion Revascularization
Time frame: 1-year
CABG
Time frame: 1-year
Target Vessel Revascularization
Time frame: 1-year
Any bleeding
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 10 Dec 2015.
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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.
Takeshi Kimura, MD, PhD principal investigator
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
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 Thienopyridine for 3 months in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.
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 1 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 10 Dec 2015. 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 Japan. 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?
Major cardiovascular and bleeding events (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 10 Dec 2015.