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

June 19, 2018 updated by: Yonsei University
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

3056

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MYEONG-KI HONG, MD, Ph.D
  • Phone Number: 82-2-2228-8460
  • Email: MKHONG61@yuhs.ac

Study Locations

      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor monotherapy
Ticagrelor monotherapy at 3 months after PCI
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular clinical events (MACCE)
Time Frame: 1 year after the procedure
1 year after the procedure
major bleeding
Time Frame: 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.
1 year after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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