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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 : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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

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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
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

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).




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

  2. All-cause or cardiovascular mortality [ Time Frame: 1 year after procedure ]
    All-cause or 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



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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

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


Locations
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Korea, Republic of
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03797651     History of Changes
Other Study ID Numbers: 4-2018-0782
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
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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Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Acute Disease
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors