ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS (STOPDAPT-2 ACS)

June 12, 2024 updated by: Takeshi Morimoto, Kyoto University, Graduate School of Medicine

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3008

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Kyoto University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months
Drug: 1-months DAPT
1-month DAPT followed by 59-month monotherapy
Active Comparator: 12-month DAPT
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
Drug: 12-month DAPT
12-month DAPT followed by 48-month monotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: 12 months
12 months
Stroke
Time Frame: 12 months
12 months
Clinically-driven target lesion revascularization
Time Frame: 60 months
60 months
Target vessel revascularization
Time Frame: 12 months
12 months
Myocardial infarction
Time Frame: 12 months
12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time Frame: 12 months
12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time Frame: 60 months
60 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time Frame: 12 months
12 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time Frame: 60 months
60 months
Upper gastrointestinal endoscopic examination or treatment
Time Frame: 60 months
60 months
Composite event of all-cause death/myocardial infarction
Time Frame: 12 months
12 months
Composite event of all-cause death/myocardial infarction
Time Frame: 60 months
60 months
All-cause death
Time Frame: 12 months
12 months
All-cause death
Time Frame: 60 months
60 months
Composite event of cardiovascular death/myocardial infarction
Time Frame: 12 months
12 months
Composite event of cardiovascular death/myocardial infarction
Time Frame: 60 months
60 months
Cardiovascular death
Time Frame: 60 months
60 months
Myocardial infarction
Time Frame: 60 months
60 months
Stroke
Time Frame: 60 months
60 months
Definite stent thrombosis
Time Frame: 12 months
Academic Research Consortium definition
12 months
Definite stent thrombosis
Time Frame: 60 months
Academic Research Consortium definition
60 months
Target lesion failure
Time Frame: 12 months
12 months
Target lesion failure
Time Frame: 60 months
60 months
Target vessel failure
Time Frame: 12 months
12 months
Target vessel failure
Time Frame: 60 months
60 months
Major adverse cardiac event
Time Frame: 12 months
Composite of cardiac death, myocardial infarction, and clinically-driven TLR
12 months
Major adverse cardiac event
Time Frame: 60 months
Composite of cardiac death, myocardial infarction, and clinically-driven TLR
60 months
Target lesion revascularization
Time Frame: 12 months
12 months
Target lesion revascularization
Time Frame: 60 months
60 months
Clinically-driven target lesion revascularization
Time Frame: 12 months
12 months
Non target lesion revascularization
Time Frame: 12 months
12 months
Non target lesion revascularization
Time Frame: 60 months
60 months
Coronary artery bypass graft
Time Frame: 12 months
12 months
Coronary artery bypass graft
Time Frame: 60 months
60 months
Target vessel revascularization
Time Frame: 60 months
60 months
Any coronary revascularization
Time Frame: 12 months
12 months
Any coronary revascularization
Time Frame: 60 months
60 months
Bleeding complications
Time Frame: 12 months
12 months
Bleeding complications
Time Frame: 60 months
60 months
Gastrointestinal bleeding
Time Frame: 12 months
12 months
Gastrointestinal bleeding
Time Frame: 60 months
60 months
Gastrointestinal complaints requiring upper gastrointestinal endoscopy
Time Frame: 12 months
12 months
Gastrointestinal complaints requiring upper gastrointestinal endoscopy
Time Frame: 60 months
60 months
Newly diagnosed cancer
Time Frame: 60 months
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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyoto University, Graduate School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Takeshi Kimura, MD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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