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
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: Ticagrelor monotherapy Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3056 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||August 1, 2015|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
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.
- Major adverse cardiovascular clinical events (MACCE) [ Time Frame: 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.
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
|Contact: Myeong-Ki Hong, MD, Ph.Demail@example.com|
|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|