TICA KOREA: Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management

• Sponsor: Seung-Jung Park (Other)
• Overall Status: Completed
• CT.gov ID: NCT02094963
• Collaborator: CardioVascular Research Foundation, Korea (Other)
• Enrollment: 800
• Locations: 10
• Arms: 2
• Actual Duration (Months): 51.9
• Patients Per Site: 80
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Angina Pectoris	Drug: Ticagrelor; Drug: Clopidogrel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial
• Actual Study Start Date: Jul 5, 2014
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor	Drug: Ticagrelor; 180mg loading and 90mg bid
Active Comparator: Clopidogrel	Drug: Clopidogrel; 600mg loading and 75mg qd

Outcome Measures

Primary Outcome Measures

1. The time to first occurrence of any bleeding event [1year]

   Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)

2. The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke [1year]

   Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke

Secondary Outcome Measures

1. The time to first occurrence of major bleeding event [1year]

   by PLAtelet inhibition and patient Outcomes(PLATO) criteria

2. The time to first occurrence of minor bleeding event [1year]

   by PLAtelet inhibition and patient Outcomes(PLATO) criteria

3. The time to first occurrence of major bleeding event or minor bleeding event [1year]

   The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

4. The time to first occurrence of major bleeding event [1year]

   The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

5. The time to first occurrence of minor bleeding event [1year]

   The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

6. The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5 [1year]

   By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events

7. The time of first occurrence of discontinuation of study medication from any bleeding event [1year]

8. Non serious adverse events [1year]

9. Adverse events following discontinuation of study medication [1year]

10. Serious adverse events [1year]

11. The time to first occurrence of death from vascular causes [1year]

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes

12. The time to first occurrence of myocardial infarction [1year]

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction

13. The time to first occurrence of stroke [1year]

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke

14. The time to occurrence of composite events [1year]

    The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)

15. The time to occurrence of death from any cause [1year]

16. Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke. [1year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 and more

• Index event of non-ST or ST segment elevation ACS

• Provision of signed informed consent

Exclusion Criteria:

• Hypersensitivity to aspirin or ticagrelor

• Oral anticoagulation therapy that cannot be stopped

• Treated with thrombolysis within 24hrs

• Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor

• Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers

• Any life-threatening condition with life expectancy less than 6months

• Mental condition (dementia, alcohol or drug abuse) which may be affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study

• High risk due to malignant hypertension

• The conditions associated with increased risk of bradycardiac events

• Subjects with severe liver disease

• Subjects requiring dialysis

• Increased bleeding risk

• History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days

• Thrombocytopenia or leukopenia

• Positive pregnancy test or is known to be pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736
2	Chungnam National University Hospital	Dae-jeon		Korea, Republic of
3	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
4	Dongguk University Gyeongju Hospital	Gyeongju		Korea, Republic of
5	Inje University Ilsan Paik Hospital	Ilsan		Korea, Republic of
6	Gachon University Gil Hospital	Incheon		Korea, Republic of
7	ChonBuk National University Hospital	Jeonju		Korea, Republic of
8	Dong-A Medical Center	Pusan		Korea, Republic of
9	Inje University Pusan Paik Hospital	Pusan		Korea, Republic of
10	Ulsan University Hospital	Ulsan		Korea, Republic of

Sponsors and Collaborators

• Seung-Jung Park
• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Jung Park, MD, PhD, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02094963
• Other Study ID Numbers: AMCCV2013-14
• First Posted: Mar 24, 2014
• Last Update Posted: Nov 30, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Seung-Jung Park, MD, PhD, Asan Medical Center: acute coronary syndrome; coronary disease; coronary artery disease
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Acute Coronary Syndrome; Myocardial Ischemia; Angina Pectoris; Syndrome; Ischemia; Clopidogrel; Ticagrelor

Study Results

No Results Posted as of Nov 30, 2018