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Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02494895
Collaborator
(none)
3,056
Enrollment
1
Location
2
Arms
93
Anticipated Duration (Months)
32.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor vs. ticagrelor monotherapy at 3 months after PCI in patients with acute coronary syndrome.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ticagrelor monotherapy
  • Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3056 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ticagrelor monotherapy

Ticagrelor monotherapy at 3 months after PCI

Drug: Ticagrelor monotherapy
Ticagrelor (Brilinta®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation. Patients will be randomized to stop aspirin at 3 months after PCI.
Other Names:
  • Brilinta®

    		•
    Active Comparator: Ticagrelor with Aspirin

    Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)

    Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)
    Ticagrelor (Brilinta®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation. Patients will be randomized to continue DAPT (aspirin+ticagrelor) up to 1 year.

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiovascular clinical events (MACCE) [1 year after the procedure]

    2. major bleeding [1 year after the procedure]

      Major bleeding means 1) any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), 2) clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit, and 3) fatal bleeding (bleeding that directly results in death within 7 days) in accordance with TIMI Bleeding Criteria.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients ≥ 19 years old

    • Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS

    • Patients without significant clinical events such as MI, stent thrombosis or revascularization until 3 months after PCI

    • Provision of informed consent

    Exclusion Criteria:

    • 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

    • Patients who treated with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, or atazanavir)

    • Patients who had history of intracranial hemorrhage

    • Moderate to severe hepatic dysfunction

    • Increased risk of bradycardia-related symptom (Guidance and reference)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02494895
    Other Study ID Numbers:
    • 1-2014-0066
    First Posted:
    Jul 10, 2015
    Last Update Posted:
    Jun 20, 2018
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Aspirin
    Ticagrelor

    Study Results

    No Results Posted as of Jun 20, 2018