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

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ClinicalTrials.gov Identifier: NCT02494895
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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
Acute Coronary Syndrome Drug: Ticagrelor monotherapy Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment) Phase 4

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

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Major adverse cardiovascular clinical events (MACCE) [ Time Frame: 1 year after the procedure ]
  2. 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.



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02494895


Contacts
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Contact: Myeong-Ki Hong, MD, Ph.D 82-2-2228-8460 mkhong61@yuhs.ac

Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: MYEONG-KI HONG, MD, Ph.D    82-2-2228-8460    MKHONG61@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02494895     History of Changes
Other Study ID Numbers: 1-2014-0066
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Myocardial Ischemia
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
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
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents