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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

Tracking Information
First Submitted Date  ICMJE January 6, 2019
First Posted Date  ICMJE January 9, 2019
Last Update Posted Date March 7, 2023
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date April 4, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2019)		 Net clinical benefit [ Time Frame: 1 year after procedure ]
A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2023)
  • Each components of net clinical benefit [ Time Frame: 1 year after procedure ]
    All-cause death, MI, stent thrombosis, stroke, major bleeding
  • Cardiovascular mortality [ Time Frame: 1 year after procedure ]
    Cardiovascular mortality
  • Major or minor bleeding [ Time Frame: 1 year after procedure ]
    Major or minor bleeding
  • Major adverse cardiac event [ Time Frame: 1 year after procedure ]
    A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2019)
  • Each components of net clinical benefit [ Time Frame: 1 year after procedure ]
    All-cause death, MI, stent thrombosis, stroke
  • All-cause or cardiovascular mortality [ Time Frame: 1 year after procedure ]
    All-cause or cardiovascular mortality
  • Major or minor bleeding [ Time Frame: 1 year after procedure ]
    Major or minor bleeding
  • Major adverse cardiac event [ Time Frame: 1 year after procedure ]
    A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
Official Title  ICMJE Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease, Acute Coronary Syndrome
Intervention  ICMJE
  • 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.
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Standard DAPT
  • 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).
    Intervention: Drug: Very-short DAPT less than 1 month after PCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2019)		 2850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 4, 2025
Estimated Primary Completion Date April 4, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Myeong-Ki Hong, MD, PhD 82-2-2228-8458 mkhong61@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03797651
Other Study ID Numbers  ICMJE 4-2018-0782
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yonsei University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Myeong-Ki Hong Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
PRS Account Yonsei University
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP