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TicAgrelor Versus CLOpidogrel in Stabilized Patients With Acute Myocardial Infarction: TALOS-AMI

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ClinicalTrials.gov Identifier: NCT02018055
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : April 2, 2021
Sponsor:
Collaborator:
Chonnam National University Hospital
Information provided by (Responsible Party):
Kiyuk Chang, MD,PhD, The Catholic University of Korea

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of clopidogrel in stabilized patients with acute myocardial infarction (AMI) who performed percutaneous coronary intervention (PCI) with drug-eluting stents (DES) compared with ticagrelor.

In this study, 2,590 patients with AMI who underwent PCI with DES and took dual antiplatelet therapy as aspirin and ticagrelor during 1 month from index PCI will be randomized to aspirin+ticagrelor versus aspirin+ clopidogrel during 11 months.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Aspirin+Ticagrelor Drug: Aspirin+Clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Open-label Trial to Compare Efficacy and Safety of Clopidogrel vs Ticagrelor in Stabilized Patients With Acute Myocardial Infarction After Percutaneous Coronary Intervention; TicAgrelor Versus CLOpidogrel in Stabilized Patients With Acute Myocardial Infarction: TALOS-AMI
Actual Study Start Date : February 14, 2014
Actual Primary Completion Date : January 21, 2021
Actual Study Completion Date : January 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Aspirin+Ticagrelor
A Group treated with Aspirin+Ticagrelor
Drug: Aspirin+Ticagrelor
Aspirin+ Ticagrelor after 1month of standard DAPT (Aspirin+Ticagrelor)

Experimental: Aspirin+Clopidogrel
A Group treated with Aspirin+Clopidogrel
Drug: Aspirin+Clopidogrel
Aspirin+ Clopidogrel after 1month of standard DAPT (Aspirin+Ticagrelor)




Primary Outcome Measures :
  1. Cumulative incidence of Net adverse clinical event [ Time Frame: 1 month to 12months after AMI ]
    Composite endpoint of MACCE (CV death, MI, or stroke) + BARC bleeding (type 2, 3 or 5) between 1 and 12 months after AMI


Secondary Outcome Measures :
  1. Cumulative incidence of BARC bleeding (type 2, 3, or 5) [ Time Frame: 1 month to 12months after AMI ]
    BARC bleeding (type 2, 3, or 5) between 1 and 12 months after AMI

  2. Cumulative incidence of Composite endpoint of MACCE (CV death, MI, or stroke) + BARC bleeding (type 3, 5) [ Time Frame: 1 month to 12months after AMI ]
    Composite endpoint of MACCE (CV death, MI, or stroke) + BARC bleeding (type 3, 5) between 1 and 12 months after AMI

  3. Cumulative incidence of Composite endpoint of MACCE (CV death, MI, or stroke) [ Time Frame: 1 month to 12months after AMI ]
    Composite endpoint of MACCE (CV death, MI, or stroke) between 1 and 12 months after AMI

  4. Cumulative incidence of All-cause death [ Time Frame: 1 month to 12months after AMI ]
    All-cause death between 1 and 12 months after AMI

  5. Cumulative incidence of CV death [ Time Frame: 1 month to 12months after AMI ]
    CV death between 1 and 12 months after AMI

  6. Cumulative incidence of Recurrent MI [ Time Frame: 1 month to 12months after AMI ]
    Recurrent MI between 1 and 12 months after AMI

  7. Cumulative incidence of Stroke [ Time Frame: 1 month to 12months after AMI ]
    Stroke between 1 and 12 months after AMI

  8. Cumulative incidence of Ischemia Driven Revascularization including PCI or CABG [ Time Frame: 1 month to 12months after AMI ]
    Ischemia Driven Revascularization including PCI or CABG between 1 and 12 months after AMI

  9. Cumulative incidence of Stent thrombosis (definite or probable) [ Time Frame: 1 month to 12months after AMI ]
    Stent thrombosis (definite or probable) between 1 and 12 months after AMI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject should meet all of the following criteria.

  1. Age >= 18 years
  2. Patients with AMI (STEMI or NSTEMI) who are administered aspirin and ticagrelor for 30 days after successful PCI with newer-generation drug eluting stents (DES)

    *Definition of AMI follows the 3rd Universal Definition of MI.

  3. Female patients with childbearing potential who agree to mandatory pregnancy test and have committed to using adequate contraception
  4. Subjects who agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate IRB of the respective institution

Exclusion Criteria:

Subject should be excluded if they apply to any of the following criteria.

  1. Cardiogenic shock
  2. Active internal bleeding, bleeding diathesis, or coagulopathy
  3. Gastrointestinal bleeding or genitourinary bleeding, hemoptysis, or vitreous hemorrhage within 2 months
  4. Major surgery within 6 weeks
  5. History of intracranial bleeding, intracranial neoplasm, intracranial arteriovenous malformation, or intracranial aneurysm
  6. Anemia (hemoglobin < 10 g/dL) or platelet count of less than 100,000/mm3 at the time of screening
  7. Concomitant treatment with oral anticoagulant agent (vitamin-K antagonists or novel oral anticoagulants such as dabigatran, rivaroxaban, apixaban, or edoxaban)
  8. Daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 inhibitors
  9. Malignancy or life expectancy of less than one year
  10. Moderate or severe hepatic dysfunction (Child Pugh B or C)
  11. Symptomatic patients with sinus bradycardia (sick sinus syndrome) or atrioventricular (AV) block (AV block grade II or III, bradycardia-induced syncope; except for patients implanted with permanent pacemaker)
  12. Symptomatic patients with chronic obstructive pulmonary disease (Medical research council grade >=3)
  13. Intolerance of or allergy to aspirin, ticagrelor or clopidogrel
  14. Subjects who are under renal replacement therapy due to end-stage renal disease or who have history of kidney transplantation
  15. Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption
  16. Subjects who are actively participating in another clinical trial with 3 months of randomization (except for observational study)
  17. Pregnant and/or lactating women
  18. Subjects considered unsuitable for this study by the investigator

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): NCT02018055


Locations
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Korea, Republic of
Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 137701
Sponsors and Collaborators
The Catholic University of Korea
Chonnam National University Hospital
Investigators
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Principal Investigator: Kiyuk Chang, MD, PhD Seoul St. Mary's Hospital
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Responsible Party: Kiyuk Chang, MD,PhD, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02018055    
Other Study ID Numbers: TALOS-AMI
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kiyuk Chang, MD,PhD, The Catholic University of Korea:
dual antiplaltelet therapy
Deescalation of P2Y12 inhibitor
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Clopidogrel
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