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

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ClinicalTrials.gov Identifier: NCT03797651
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease, Acute Coronary Syndrome Drug: Standard DAPT Drug: Very-short DAPT less than 1 month after PCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : April 4, 2025
Estimated Study Completion Date : April 4, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Net clinical benefit [ Time Frame: 1 year after procedure ]
    A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding


Secondary Outcome Measures :
  1. Each components of net clinical benefit [ Time Frame: 1 year after procedure ]
    All-cause death, MI, stent thrombosis, stroke, major bleeding

  2. Cardiovascular mortality [ Time Frame: 1 year after procedure ]
    Cardiovascular mortality

  3. Major or minor bleeding [ Time Frame: 1 year after procedure ]
    Major or minor bleeding

  4. Major adverse cardiac event [ Time Frame: 1 year after procedure ]
    A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797651


Contacts
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Contact: Myeong-Ki Hong, MD, PhD 82-2-2228-8458 mkhong61@yuhs.ac

Locations
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Korea, Republic of
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Myeong-Ki Hong, MD, PhD    82-2-2228-8458    mkhong61@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Myeong-Ki Hong Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03797651    
Other Study ID Numbers: 4-2018-0782
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Syndrome
Acute Disease
Disease
Pathologic Processes
Coronary Disease
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes