Coronary Artery DiseasePhase 4STOPDAPT-2NCT02619760
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
A Phase 4 study testing 1-month DAPT and 12-month DAPT in people with Coronary Artery Disease, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 1-month DAPT and 12-month DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,045 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2015to 31 Dec 2023
- 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 received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
- Patients who are capable of oral dual antiplatelet therapy consisting of asprin and P2Y12 receptor antagonist
Who cannot join
- Patients requiring oral anticoagulants
- Patients with medical history of intracranial hemorrhage
- Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
- Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents (Xience) implanted at the time of enrollment
- Patients comfirmed to have no tolerability to clopidgorel before enrollment
- Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
- Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES).
Read the detailed description
The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. However, serious hemorrhagic complications associated with a prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators therefore planned a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group. Primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. At first, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- 1-month DAPT, 12-month DAPT
- Keywords
- Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- 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.
1-month DAPTDrug
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
12-month DAPTDrug
12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
| Study group | Role | What they receive |
|---|---|---|
| 1-month DAPT | Active comparator | 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy Receives: Drug: 1-month DAPT |
| 12-month DAPT | Active comparator | 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy Receives: Drug: 12-month DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Measured: 12-month
Secondary outcomes (44)
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Measured: 12-month
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Measured: 60-month
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Measured: 12-month
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Measured: 60-month
Upper gastrointestinal endoscopic examination or treatment
Measured: 60-month
Composite event of all-cause death/myocardial infarction
Measured: 12-month
Composite event of all-cause death/myocardial infarction
Measured: 60-month
All-cause death
Measured: 12-month
All-cause death
Measured: 60-month
Composite event of cardiovascular death/myocardial infarction
Measured: 12-month
Composite event of cardiovascular death/myocardial infarction
Measured: 60-month
Cardiovascular death
Measured: 12-month
Cardiovascular death
Measured: 60-month
Myocardial infarction
Measured: 12-month
Myocardial infarction
Measured: 60-month
Stroke
a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage
Measured: 12-month
Stroke
a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage
Measured: 60-month
MACE (Major Adverse Cardiac Events)
Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
Measured: 12-month
MACE (Major Adverse Cardiac Events)
Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
Measured: 60-month
Definite stent thrombosis
Measured: 12-month
Definite stent thrombosis
Measured: 60-month
Target lesion failure
Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
Measured: 12-month
Target lesion failure
Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
Measured: 60-month
Target vessel failure
Measured: 12-month
Target vessel failure
Measured: 60-month
Target lesion revasucularization
PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications
Measured: 12-month
Target lesion revasucularization
PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications
Measured: 60-month
Clinically-driven target lesion revascularization
the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Measured: 12-month
Clinically-driven target lesion revascularization
the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Measured: 60-month
Non target lesion revascularization
Measured: 12-month
Non target lesion revascularization
Measured: 60-month
Coronary artery bypass graft
Measured: 12-month
Coronary artery bypass graft
Measured: 60-month
Target vessel revascularization
Measured: 12-month
Target vessel revascularization
Measured: 60-month
Any coronary reascluarization
Measured: 12-month
Any coronary reascluarization
Measured: 60-month
Bleeding complications
Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
Measured: 12-month
Bleeding complications
Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
Measured: 60-month
Gastrointestinal bleeding
Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
Measured: 12-month
Gastrointestinal bleeding
Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
Measured: 60-month
Gastrointestinal complaints
Symptoms requiring upper gastrointestinal endoscopic study or treatment
Measured: 12-month
Gastrointestinal complaints
Symptoms requiring upper gastrointestinal endoscopic study or treatment
Measured: 60-month
Newly diagnosed cancer
The endpoint is a newly diagnosed malignancy during the follow-up period that has not been previously diagnosed before enrollment. This does not include recurrent tumor after remission, includes early-stage cancer eligible for endoscopic treatment, and includes the tumors which are not diagnosed by tissue biopsy but are judged to be clinically malignant on imaging.
Measured: 60-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion8 Dec 2018
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- 3,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, PhD, Study chair, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619760
- Sponsor's protocol ID
- C1114
- Other IDs
- UMIN000019948
- Acronym
- STOPDAPT-2
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2015
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Imada K, Suwa S, Isawa T, Ando K, Fujita T, Kadota K, Tokuyama H, Sakamoto H, Suzuki H, Wakabayashi K, Ono K, Hayashi F, Tanabe K, Akao M, Onishi Y, Yoshida R, Kusuyama T, Tamura T, Onoue Y, Yagi M, Kaitani K, Kimura T; STOPDAPT-2 ACS investigators. Clopidogrel Versus Aspirin Monotherapy Beyond 1 Year After PCI: The Final 5-Year Results of the STOPDAPT-2 ACS and STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2026 Jun;19(6):e016280. doi: 10.1161/CIRCINTERVENTIONS.125.016280. Epub 2026 Mar 18.
PubMed 41847750Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, Natsuaki M, Yamaji K, Domei T, Ogita M, Ohya M, Tatsushima S, Suzuki H, Tada T, Ishii M, Nikaido A, Watanabe N, Fujii S, Mori H, Nishikura T, Suematsu N, Hayashi F, Komiyama K, Shigematsu T, Isawa T, Suwa S, Ando K, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Jan 9;16(1):19-31. doi: 10.1016/j.jcin.2022.09.053. Epub 2022 Dec 14.
PubMed 36599584Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2022 Aug;15(8):e012004. doi: 10.1161/CIRCINTERVENTIONS.122.012004. Epub 2022 Aug 1.
PubMed 35912647Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244.
PubMed 35234821Yamamoto K, Watanabe H, Morimoto T, Domei T, Ohya M, Ogita M, Takagi K, Suzuki H, Nikaido A, Ishii M, Fujii S, Natsuaki M, Yasuda S, Kaneko T, Tamura T, Tamura T, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Igarashi Hanaoka K, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial. Circ Cardiovasc Interv. 2021 May;14(5):e010384. doi: 10.1161/CIRCINTERVENTIONS.120.010384. Epub 2021 May 18.
PubMed 34003662Watanabe H, Morimoto T, Ogita M, Suwa S, Natsuaki M, Suematsu N, Koeda Y, Morino Y, Nikaido A, Hata Y, Doi M, Hibi K, Kimura K, Yoda S, Kaneko T, Nishida K, Kawai K, Yamaguchi K, Wakatsuki T, Tonoike N, Yamamoto M, Shimizu S, Shimohama T, Ako J, Kimura T; STOPDAPT-2 Investigators. Influence of CYP2C19 genotypes for the effect of 1-month dual antiplatelet therapy followed by clopidogrel monotherapy relative to 12-month dual antiplatelet therapy on clinical outcomes after percutaneous coronary intervention: a genetic substudy from the STOPDAPT-2. Cardiovasc Interv Ther. 2021 Oct;36(4):403-415. doi: 10.1007/s12928-020-00719-6. Epub 2020 Nov 12.
PubMed 33184726Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 investigators. Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial. Cardiovasc Interv Ther. 2021 Jan;36(1):91-103. doi: 10.1007/s12928-020-00651-9. Epub 2020 Feb 21.
PubMed 32086787Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2414-2427. doi: 10.1001/jama.2019.8145.
PubMed 31237644
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
- ClinicalTrials.gov ID
- NCT02619760
- Acronym / sponsor ID
- STOPDAPT-2 / C1114
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,045 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Dec 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 evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES).
Detailed description
The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. However, serious hemorrhagic complications associated with a prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators therefore planned a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group. Primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. At first, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-month DAPT | Active comparator | Drug: 1-month DAPT1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy |
| 12-month DAPT | Active comparator | Drug: 12-month DAPT1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
- Patients who are capable of oral dual antiplatelet therapy consisting of asprin and P2Y12 receptor antagonist
Key exclusion criteria (7 listed)
- Patients requiring oral anticoagulants
- Patients with medical history of intracranial hemorrhage
- Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
- Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents (Xience) implanted at the time of enrollment
- Patients comfirmed to have no tolerability to clopidgorel before enrollment
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 |
|---|---|---|
| 1-month DAPT1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists | Drug | 1-month DAPT |
| 12-month DAPT12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists | Drug | 12-month DAPT |
Primary outcome
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
Time frame: 12-month
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
44 secondary outcomes
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 12-month
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 60-month
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 12-month
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 60-month
Upper gastrointestinal endoscopic examination or treatment
Time frame: 60-month
Composite event of all-cause death/myocardial infarction
Time frame: 12-month
Composite event of all-cause death/myocardial infarction
Time frame: 60-month
All-cause death
Time frame: 12-month
All-cause death
Time frame: 60-month
Composite event of cardiovascular death/myocardial infarction
Time frame: 12-month
Composite event of cardiovascular death/myocardial infarction
Time frame: 60-month
Cardiovascular death
Time frame: 12-month
Cardiovascular death
Time frame: 60-month
Myocardial infarction
Time frame: 12-month
Myocardial infarction
Time frame: 60-month
Stroke
Time frame: 12-month
Stroke
Time frame: 60-month
MACE (Major Adverse Cardiac Events)
Time frame: 12-month
MACE (Major Adverse Cardiac Events)
Time frame: 60-month
Definite stent thrombosis
Time frame: 12-month
Definite stent thrombosis
Time frame: 60-month
Target lesion failure
Time frame: 12-month
Target lesion failure
Time frame: 60-month
Target vessel failure
Time frame: 12-month
Target vessel failure
Time frame: 60-month
Target lesion revasucularization
Time frame: 12-month
Target lesion revasucularization
Time frame: 60-month
Clinically-driven target lesion revascularization
Time frame: 12-month
Clinically-driven target lesion revascularization
Time frame: 60-month
Non target lesion revascularization
Time frame: 12-month
Non target lesion revascularization
Time frame: 60-month
Coronary artery bypass graft
Time frame: 12-month
Coronary artery bypass graft
Time frame: 60-month
Target vessel revascularization
Time frame: 12-month
Target vessel revascularization
Time frame: 60-month
Any coronary reascluarization
Time frame: 12-month
Any coronary reascluarization
Time frame: 60-month
Bleeding complications
Time frame: 12-month
Bleeding complications
Time frame: 60-month
Gastrointestinal bleeding
Time frame: 12-month
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 14 Jun 2024.
- Derived from this study: PubMed 41847750Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Imada K, Suwa S, Isawa T, Ando K, Fujita T, Kadota K, Tokuyama H, Sakamoto H, Suzuki H, Wakabayashi K, Ono K, Hayashi F, Tanabe K, Akao M, Onishi Y, Yoshida R, Kusuyama T, Tamura T, Onoue Y, Yagi M, Kaitani K, Kimura T; STOPDAPT-2 ACS investigators. Clopidogrel Versus Aspirin Monotherapy Beyond 1 Year After PCI: The Final 5-Year Results of the STOPDAPT-2 ACS and STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2026 Jun;19(6):e016280. doi: 10.1161/CIRCINTERVENTIONS.125.016280. Epub 2026 Mar 18.
- Derived from this study: PubMed 36599584Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, Natsuaki M, Yamaji K, Domei T, Ogita M, Ohya M, Tatsushima S, Suzuki H, Tada T, Ishii M, Nikaido A, Watanabe N, Fujii S, Mori H, Nishikura T, Suematsu N, Hayashi F, Komiyama K, Shigematsu T, Isawa T, Suwa S, Ando K, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Jan 9;16(1):19-31. doi: 10.1016/j.jcin.2022.09.053. Epub 2022 Dec 14.
- Derived from this study: PubMed 35912647Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2022 Aug;15(8):e012004. doi: 10.1161/CIRCINTERVENTIONS.122.012004. Epub 2022 Aug 1.
- Derived from this study: PubMed 35234821Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244.
- Derived from this study: PubMed 34003662Yamamoto K, Watanabe H, Morimoto T, Domei T, Ohya M, Ogita M, Takagi K, Suzuki H, Nikaido A, Ishii M, Fujii S, Natsuaki M, Yasuda S, Kaneko T, Tamura T, Tamura T, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Igarashi Hanaoka K, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial. Circ Cardiovasc Interv. 2021 May;14(5):e010384. doi: 10.1161/CIRCINTERVENTIONS.120.010384. Epub 2021 May 18.
- Derived from this study: PubMed 33184726Watanabe H, Morimoto T, Ogita M, Suwa S, Natsuaki M, Suematsu N, Koeda Y, Morino Y, Nikaido A, Hata Y, Doi M, Hibi K, Kimura K, Yoda S, Kaneko T, Nishida K, Kawai K, Yamaguchi K, Wakatsuki T, Tonoike N, Yamamoto M, Shimizu S, Shimohama T, Ako J, Kimura T; STOPDAPT-2 Investigators. Influence of CYP2C19 genotypes for the effect of 1-month dual antiplatelet therapy followed by clopidogrel monotherapy relative to 12-month dual antiplatelet therapy on clinical outcomes after percutaneous coronary intervention: a genetic substudy from the STOPDAPT-2. Cardiovasc Interv Ther. 2021 Oct;36(4):403-415. doi: 10.1007/s12928-020-00719-6. Epub 2020 Nov 12.
- Derived from this study: PubMed 32086787Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 investigators. Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial. Cardiovasc Interv Ther. 2021 Jan;36(1):91-103. doi: 10.1007/s12928-020-00651-9. Epub 2020 Feb 21.
- Derived from this study: PubMed 31237644Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2414-2427. doi: 10.1001/jama.2019.8145.
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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 study chair
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 1-month DAPT and 12-month DAPT in people with Coronary Artery Disease, run by Kyoto University, Graduate School of Medicine 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 2 inclusion and 7 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 14 Jun 2024. 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?
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding (time frame: 12-month). 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 NCT02619760, which also lists 8 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 14 Jun 2024.