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

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease, Acute Coronary Syndrome
• Intervention / Treatment: Drug: Standard DAPT; Drug: Very-short DAPT less than 1 month after PCI

• Study Type: Interventional
• Enrollment (Anticipated): 2850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Myeong-Ki Hong, MD, PhD; Phone Number: 82-2-2228-8458; Email: mkhong61@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
    • Contact: Myeong-Ki Hong, MD, PhD; Phone Number: 82-2-2228-8458; Email: mkhong61@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥19 years old
2. Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
3. Provision of informed consent

Exclusion Criteria:

1. Age> 80 years
2. Increased risk of bleeding, anemia, thrombocytopenia
3. A need for oral anticoagulation therapy
4. Pregnant women or women with potential childbearing
5. Life expectancy < 1 year

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard DAPT; 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.	Drug: Standard DAPT; 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.
Experimental: Very-short DAPT within 1 month; 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).	Drug: Very-short DAPT less than 1 month after PCI; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net clinical benefit	A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding	1 year after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major or minor bleeding	Major or minor bleeding	1 year after procedure
Major adverse cardiac event	A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization	1 year after procedure
Each components of net clinical benefit	All-cause death, MI, stent thrombosis, stroke, major bleeding	1 year after procedure
Cardiovascular mortality	Cardiovascular mortality	1 year after procedure

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Myeong-Ki Hong, Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Anticipated): April 4, 2025
• Study Completion (Anticipated): April 4, 2025

Study Registration Dates

• First Submitted: January 6, 2019
• First Submitted That Met QC Criteria: January 6, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Disease; Coronary Disease; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome; Acute Disease
• Other Study ID Numbers: 4-2018-0782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No