ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study (STOPDAPT-2)
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ClinicalTrials.gov Identifier: NCT02619760 |
Recruitment Status :
Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : January 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Drug: 1-month DAPT Drug: 12-month DAPT | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3045 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study |
Actual Study Start Date : | December 2015 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy
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Drug: 1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists |
Active Comparator: 12-month DAPT
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
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Drug: 12-month DAPT
12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists |
- 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
- 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 ]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
- Stroke [ Time Frame: 60-month ]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
- MACE (Major Adverse Cardiac Events) [ Time Frame: 12-month ]Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
- MACE (Major Adverse Cardiac Events) [ Time Frame: 60-month ]Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
- Definite stent thrombosis [ Time Frame: 12-month ]
- Definite stent thrombosis [ Time Frame: 60-month ]
- Target lesion failure [ Time Frame: 12-month ]Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
- Target lesion failure [ Time Frame: 60-month ]Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
- Target vessel failure [ Time Frame: 12-month ]
- Target vessel failure [ Time Frame: 60-month ]
- Target lesion revasucularization [ Time Frame: 12-month ]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
- Target lesion revasucularization [ Time Frame: 60-month ]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
- Clinically-driven target lesion revascularization [ Time Frame: 12-month ]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.
- Clinically-driven target lesion revascularization [ Time Frame: 60-month ]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.
- 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 ]Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
- Bleeding complications [ Time Frame: 60-month ]Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
- Gastrointestinal bleeding [ Time Frame: 12-month ]Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
- Gastrointestinal bleeding [ Time Frame: 60-month ]Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
- Gastrointestinal complaints [ Time Frame: 12-month ]Symptoms requiring upper gastrointestinal endoscopic study or treatment
- Gastrointestinal complaints [ Time Frame: 60-month ]Symptoms requiring upper gastrointestinal endoscopic study or treatment
- Newly diagnosed cancer [ Time Frame: 60-month ]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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619760
Japan | |
Division of Cardiology, Kyoto University Hospital | |
Kyoto, Japan, 606-8507 |
Study Chair: | Takeshi Kimura, MD, PhD | Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine |
Responsible Party: | Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine |
ClinicalTrials.gov Identifier: | NCT02619760 |
Other Study ID Numbers: |
C1114 UMIN000019948 ( Other Identifier: UMIN ) |
First Posted: | December 2, 2015 Key Record Dates |
Last Update Posted: | January 26, 2022 |
Last Verified: | January 2022 |
Percutaneous Coronary Intervention Platelet Aggregation Inhibitors |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |