Acute Coronary SyndromePhase 4STOPDAPT-2 ACSNCT03462498
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS
A Phase 4 study testing 1-months DAPT and 12-month DAPT in people with Acute Coronary Syndrome and Acute Myocardial Infarction, 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) under the setting of acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- 1-months DAPT and 12-month DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,008 participants
- Where
- 1 siteJapan
- Study dates
- 2 Apr 2018to 31 Mar 2026
- 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 under the setting of acute coronary syndrome
- Patients who are capable of oral dual antiplatelet therapy consisting of aspirin 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 implanted at the time of enrollment
- Patients confirmed to have no tolerability to clopidogrel before enrollment
- Patients requiring continuous administration of antiplatelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Safety of Reducing Dual Antiplatelet Therapy (DAPT) Duration to 1 Month for Patients With Acute Coronary Syndrome (ACS) After Implantation of Everolimus-eluting Cobalt-chromium Stent
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) under the setting of acute coronary syndrome (ACS).
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. Especially guidelines recommend 1-year DAPT for patients with acute coronary syndrome (ACS), though its rational is based on the study more than 15 years old. However, serious hemorrhagic complications associated with 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 already planned and started 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 (STOPDAPT-2; NCT02619760), where 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. In STOPDAPT-2, 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. The proportion of patients with ACS is about 30-40% in STOPDAPT-2 and the power is insufficient to evaluate the safety and efficacy of 1-month DAPT regimen specifically for patients with ACS. Therefore the investigators planned the current study to enroll patients of ACS with the same protocol as STOPDAPT-2.
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Being tested
- 1-months DAPT, 12-month DAPT
- Keywords
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-months DAPTDrug
1-month DAPT followed by 59-month monotherapy
12-month DAPTDrug
12-month DAPT followed by 48-month monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1-month DAPT | Active comparator | 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months Receives: Drug: 1-months DAPT |
| 12-month DAPT | Active comparator | 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months 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 defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Measured: 12 months
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: 60 months
Secondary outcomes (44)
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Measured: 12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Measured: 60 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Measured: 12 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Measured: 60 months
Upper gastrointestinal endoscopic examination or treatment
Measured: 60 months
Composite event of all-cause death/myocardial infarction
Measured: 12 months
Composite event of all-cause death/myocardial infarction
Measured: 60 months
All-cause death
Measured: 12 months
All-cause death
Measured: 60 months
Composite event of cardiovascular death/myocardial infarction
Measured: 12 months
Composite event of cardiovascular death/myocardial infarction
Measured: 60 months
Cardiovascular death
Measured: 12 months
Cardiovascular death
Measured: 60 months
Myocardial infarction
Measured: 12 months
Myocardial infarction
Measured: 60 months
Stroke
Measured: 12 months
Stroke
Measured: 60 months
Definite stent thrombosis
Academic Research Consortium definition
Measured: 12 months
Definite stent thrombosis
Academic Research Consortium definition
Measured: 60 months
Target lesion failure
Measured: 12 months
Target lesion failure
Measured: 60 months
Target vessel failure
Measured: 12 months
Target vessel failure
Measured: 60 months
Major adverse cardiac event
Composite of cardiac death, myocardial infarction, and clinically-driven TLR
Measured: 12 months
Major adverse cardiac event
Composite of cardiac death, myocardial infarction, and clinically-driven TLR
Measured: 60 months
Target lesion revascularization
Measured: 12 months
Target lesion revascularization
Measured: 60 months
Clinically-driven target lesion revascularization
Measured: 12 months
Clinically-driven target lesion revascularization
Measured: 60 months
Non target lesion revascularization
Measured: 12 months
Non target lesion revascularization
Measured: 60 months
Coronary artery bypass graft
Measured: 12 months
Coronary artery bypass graft
Measured: 60 months
Target vessel revascularization
Measured: 12 months
Target vessel revascularization
Measured: 60 months
Any coronary revascularization
Measured: 12 months
Any coronary revascularization
Measured: 60 months
Bleeding complications
Measured: 12 months
Bleeding complications
Measured: 60 months
Gastrointestinal bleeding
Measured: 12 months
Gastrointestinal bleeding
Measured: 60 months
Gastrointestinal complaints requiring upper gastrointestinal endoscopy
Measured: 12 months
Gastrointestinal complaints requiring upper gastrointestinal endoscopy
Measured: 60 months
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 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start2 Apr 2018
- Primary completion31 Dec 2021
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,008 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, Principal investigator, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462498
- Sponsor's protocol ID
- C1348
- Acronym
- STOPDAPT-2 ACS
- Status last verified
- Jun 2024
- First submitted
- 6 Mar 2018
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, 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 DAPT in Patients With High Bleeding Risk or Complex PCI. JACC Asia. 2023 Jan 10;3(1):31-46. doi: 10.1016/j.jacasi.2022.09.011. eCollection 2023 Feb.
PubMed 36873770Yamamoto 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 35234821
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
- Study to Evaluate the Safety of Reducing Dual Antiplatelet Therapy (DAPT) Duration to 1 Month for Patients With Acute Coronary Syndrome (ACS) After Implantation of Everolimus-eluting Cobalt-chromium Stent
- ClinicalTrials.gov ID
- NCT03462498
- Acronym / sponsor ID
- STOPDAPT-2 ACS / C1348
- Conditions
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Keywords
- Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,008 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 12 Mar 2018 (actual)
- 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) under the setting of acute coronary syndrome (ACS).
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. Especially guidelines recommend 1-year DAPT for patients with acute coronary syndrome (ACS), though its rational is based on the study more than 15 years old. However, serious hemorrhagic complications associated with 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 already planned and started 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 (STOPDAPT-2; NCT02619760), where 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. In STOPDAPT-2, 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. The proportion of patients with ACS is about 30-40% in STOPDAPT-2 and the power is insufficient to evaluate the safety and efficacy of 1-month DAPT regimen specifically for patients with ACS. Therefore the investigators planned the current study to enroll patients of ACS with the same protocol as STOPDAPT-2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-month DAPT | Active comparator | Drug: 1-months DAPT1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months |
| 12-month DAPT | Active comparator | Drug: 12-month DAPT1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months |
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 under the setting of acute coronary syndrome
- Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and P2Y12 receptor antagonist
Key exclusion criteria (6 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 implanted at the time of enrollment
- Patients confirmed to have no tolerability to clopidogrel 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-months DAPT1-month DAPT followed by 59-month monotherapy | Drug | 1-month DAPT |
| 12-month DAPT12-month DAPT followed by 48-month monotherapy | Drug | 12-month DAPT |
Primary outcome
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
Time frame: 12 months
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
Time frame: 60 months
44 secondary outcomes
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 60 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 12 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 60 months
Upper gastrointestinal endoscopic examination or treatment
Time frame: 60 months
Composite event of all-cause death/myocardial infarction
Time frame: 12 months
Composite event of all-cause death/myocardial infarction
Time frame: 60 months
All-cause death
Time frame: 12 months
All-cause death
Time frame: 60 months
Composite event of cardiovascular death/myocardial infarction
Time frame: 12 months
Composite event of cardiovascular death/myocardial infarction
Time frame: 60 months
Cardiovascular death
Time frame: 12 months
Cardiovascular death
Time frame: 60 months
Myocardial infarction
Time frame: 12 months
Myocardial infarction
Time frame: 60 months
Stroke
Time frame: 12 months
Stroke
Time frame: 60 months
Definite stent thrombosis
Time frame: 12 months
Definite stent thrombosis
Time frame: 60 months
Target lesion failure
Time frame: 12 months
Target lesion failure
Time frame: 60 months
Target vessel failure
Time frame: 12 months
Target vessel failure
Time frame: 60 months
Major adverse cardiac event
Time frame: 12 months
Major adverse cardiac event
Time frame: 60 months
Target lesion revascularization
Time frame: 12 months
Target lesion revascularization
Time frame: 60 months
Clinically-driven target lesion revascularization
Time frame: 12 months
Clinically-driven target lesion revascularization
Time frame: 60 months
Non target lesion revascularization
Time frame: 12 months
Non target lesion revascularization
Time frame: 60 months
Coronary artery bypass graft
Time frame: 12 months
Coronary artery bypass graft
Time frame: 60 months
Target vessel revascularization
Time frame: 12 months
Target vessel revascularization
Time frame: 60 months
Any coronary revascularization
Time frame: 12 months
Any coronary revascularization
Time frame: 60 months
Bleeding complications
Time frame: 12 months
Bleeding complications
Time frame: 60 months
Gastrointestinal bleeding
Time frame: 12 months
Results and safety
Results are not available in the source record.
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 36873770Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, 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 DAPT in Patients With High Bleeding Risk or Complex PCI. JACC Asia. 2023 Jan 10;3(1):31-46. doi: 10.1016/j.jacasi.2022.09.011. eCollection 2023 Feb.
- 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.
- Individual participant dataSharing planned: No
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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 principal investigator
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-months DAPT and 12-month DAPT in people with Acute Coronary Syndrome and Acute Myocardial Infarction, 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 6 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: status not confirmed, 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?
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?
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 (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT03462498, which also lists 5 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.