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Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

Primary Purpose

Coronary Artery Disease, Acute Coronary Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Standard DAPT

Very-short DAPT less than 1 month after PCI

About this trial

This is an interventional treatment trial for Coronary Artery Disease, Acute Coronary Syndrome

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard DAPT

Very-short DAPT within 1 month

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Net clinical benefit

A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding

Secondary Outcome Measures

Each components of net clinical benefit

All-cause death, MI, stent thrombosis, stroke, major bleeding

Cardiovascular mortality

Major or minor bleeding

Major adverse cardiac event

A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization

Full Information

NCT ID

NCT03797651

First Posted

January 6, 2019

Last Updated

March 3, 2023

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03797651

Brief Title

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

Official Title

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 24, 2019 (Actual)

Primary Completion Date

April 4, 2025 (Anticipated)

Study Completion Date

April 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard DAPT

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Very-short DAPT within 1 month

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Standard DAPT

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Very-short DAPT less than 1 month after PCI

Intervention Description

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).

Primary Outcome Measure Information:

Title

Net clinical benefit

Description

A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding

Time Frame

1 year after procedure

Secondary Outcome Measure Information:

Title

Each components of net clinical benefit

Description

All-cause death, MI, stent thrombosis, stroke, major bleeding

Time Frame

1 year after procedure

Title

Cardiovascular mortality

Description

Cardiovascular mortality

Time Frame

1 year after procedure

Title

Major or minor bleeding

Description

Major or minor bleeding

Time Frame

1 year after procedure

Title

Major adverse cardiac event

Description

A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization

Time Frame

1 year after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Myeong-Ki Hong, MD, PhD

Phone

82-2-2228-8458

mkhong61@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myeong-Ki Hong

Organizational Affiliation

Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Myeong-Ki Hong, MD, PhD

Phone

82-2-2228-8458

mkhong61@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

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