Coronary Artery Disease, Acute Coronary SyndromeNCT03797651
Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
A study testing Standard DAPT and Very-short DAPT less than 1 month after PCI in people with Coronary Artery Disease, Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Standard DAPT and Very-short DAPT less than 1 month after PCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,850 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Apr 2019to 4 Apr 2025
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥19 years old
- Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
- Provision of informed consent
Who cannot join
- Age> 80 years
- Increased risk of bleeding, anemia, thrombocytopenia
- A need for oral anticoagulation therapy
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Seoul, 03722
Myeong-Ki Hong, MD, PhD, 82-2-2228-8458, mkhong61@yuhs.ac
About this study
We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.
- Being tested
- Standard DAPT, Very-short DAPT less than 1 month after PCI
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DAPTDrug
Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.
Very-short DAPT less than 1 month after PCIDrug
Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).
| Study group | Role | What they receive |
|---|---|---|
| Standard DAPT | Active comparator | Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day. Receives: Drug: Standard DAPT |
| Very-short DAPT within 1 month | Experimental | Patient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization). Receives: Drug: Very-short DAPT less than 1 month after PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net clinical benefit
A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding
Measured: 1 year after procedure
Secondary outcomes (4)
Each components of net clinical benefit
All-cause death, MI, stent thrombosis, stroke, major bleeding
Measured: 1 year after procedure
Cardiovascular mortality
Cardiovascular mortality
Measured: 1 year after procedure
Major or minor bleeding
Major or minor bleeding
Measured: 1 year after procedure
Major adverse cardiac event
A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization
Measured: 1 year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start24 Apr 2019
- Primary completion4 Apr 2025 (estimated)
- Study completion4 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease, Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myeong-Ki Hong, Principal investigator, Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797651
- Sponsor's protocol ID
- 4-2018-0782
- Status last verified
- Mar 2023
- First submitted
- 6 Jan 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Lee J, Kim SY, Jeon HS, Lee JW, Ahn SG, Lee YJ, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Hong SJ, Youn YJ. Optimal timing of aspirin discontinuation with ticagrelor monotherapy in acute coronary syndrome: a post hoc comparative analysis from the TICO and T-PASS trials. EuroIntervention. 2026 Feb 16;22(4):232-242. doi: 10.4244/EIJ-D-25-00832.
PubMed 41697655Hong SJ, Lee SJ, Suh Y, Yun KH, Kang TS, Shin S, Kwon SW, Lee JW, Cho DK, Park JK, Bae JW, Kang WC, Kim S, Lee YJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) Investigators. Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial. Circulation. 2024 Feb 20;149(8):562-573. doi: 10.1161/CIRCULATIONAHA.123.066943. Epub 2023 Oct 25.
PubMed 37878786
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
- ClinicalTrials.gov ID
- NCT03797651
- Acronym / sponsor ID
- 4-2018-0782
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,850 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 4 Apr 2025 (estimated)
- Study completion
- 4 Apr 2025 (estimated)
- First posted
- 9 Jan 2019 (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.
We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard DAPT | Active comparator | Drug: Standard DAPTPatient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day. |
| Very-short DAPT within 1 month | Experimental | Drug: Very-short DAPT less than 1 month after PCIPatient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization). |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥19 years old
- Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
- Provision of informed consent
Key exclusion criteria (5 listed)
- Age> 80 years
- Increased risk of bleeding, anemia, thrombocytopenia
- A need for oral anticoagulation therapy
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
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 |
|---|---|---|
| Standard DAPTPatient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day. | Drug | Standard DAPT |
| Very-short DAPT less than 1 month after PCIPatient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization). | Drug | Very-short DAPT within 1 month |
Primary outcome
Net clinical benefit
Time frame: 1 year after procedure
A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding
4 secondary outcomes
Each components of net clinical benefit
Time frame: 1 year after procedure
Cardiovascular mortality
Time frame: 1 year after procedure
Major or minor bleeding
Time frame: 1 year after procedure
Major adverse cardiac event
Time frame: 1 year after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 41697655Lee JH, Lee J, Kim SY, Jeon HS, Lee JW, Ahn SG, Lee YJ, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Hong SJ, Youn YJ. Optimal timing of aspirin discontinuation with ticagrelor monotherapy in acute coronary syndrome: a post hoc comparative analysis from the TICO and T-PASS trials. EuroIntervention. 2026 Feb 16;22(4):232-242. doi: 10.4244/EIJ-D-25-00832.
- Derived from this study: PubMed 37878786Hong SJ, Lee SJ, Suh Y, Yun KH, Kang TS, Shin S, Kwon SW, Lee JW, Cho DK, Park JK, Bae JW, Kang WC, Kim S, Lee YJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) Investigators. Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial. Circulation. 2024 Feb 20;149(8):562-573. doi: 10.1161/CIRCULATIONAHA.123.066943. Epub 2023 Oct 25.
- Individual participant dataSharing planned: Undecided
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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.
Myeong-Ki Hong principal investigator
Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard DAPT and Very-short DAPT less than 1 month after PCI in people with Coronary Artery Disease, Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 5 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 7 Mar 2023. 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 South Korea. 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.
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?
Contact Myeong-Ki Hong, MD, PhD (82-2-2228-8458, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net clinical benefit (time frame: 1 year after procedure). 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 NCT03797651, which also lists 2 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 7 Mar 2023.