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

NCT03797651 | Unknown DMC

• 1 other identifier: 4-2018-0782
• Study Type: interventional
• Target: 2,850
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease, Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Net clinical benefit

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

  1 year after procedure

Secondary Outcomes (4)

• Each components of net clinical benefit

  1 year after procedure

• Cardiovascular mortality

  1 year after procedure

• Major or minor bleeding

  1 year after procedure

• Major adverse cardiac event

  1 year after procedure

Study Arms (2)

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.

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).

Drug: Very-short DAPT less than 1 month after PCI

Interventions

Standard DAPT DRUG

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.

Standard DAPT

Very-short DAPT less than 1 month after PCI DRUG

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).

Very-short DAPT within 1 month

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

• Hong 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.

  PMID: 37878786 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Myeong-Ki Hong

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeong-Ki Hong, MD, PhD

CONTACT

82-2-2228-8458; mkhong61@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 9, 2019
• Study Start: April 24, 2019
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

KR (1)