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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease, Acute Coronary Syndrome
• Interventions: Drug: Standard DAPT; Drug: Very-short DAPT less than 1 month after PCI

• Registration Number: NCT03797651
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-06
• Study First Posted: 2019-01-09
• Study Start: 2019-04-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-07
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2850

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard DAPT	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.
Very-short DAPT within 1 month	Very-short DAPT less than 1 month after PCI	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).

Primary Outcome Measures

Name	Time	Method
Net clinical benefit	1 year after procedure	A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of