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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The Catholic University of Korea
Sponsor:
Collaborator:
Chonnam National University Hospital
Information provided by (Responsible Party):
Ki-Bae Seung, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT02018055
First received: December 17, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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, 3,288 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 and ticagrelor versus aspirin and clopidogrel during 11 months.


Condition Intervention
Acute Myocardial Infarction
Drug: Ticagrelor
Drug: Clopidogrel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Cumulative incidence rate of MACCE(CV death, MI, stroke) plus BARC bleeding(type 2,3,or 5) at 1 year from baseline. [ Time Frame: 1 month to 12months ] [ Designated as safety issue: No ]
    Composite endpoint of cardiac death, myocardial infarction, stroke, and bleeding (BARC bleeding type 2, 3, or 5) at one year after index percutaneous coronary intervention


Secondary Outcome Measures:
  • Cumulative incidence rate of MACCE(CV death, MI, stroke) at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of MACCE(CV death, MI, stroke) at each visit.

  • Cumulative incidence rate of Bleedings according to the BARC definitions (type 2, 3 or 5) at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Bleedings according to the BARC definitions (type 2, 3 or 5) at each visit.

  • Cumulative incidence rate of Ischemia Driven Revascularization including PCI or CABG at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Ischemia Driven Revascularization including PCI or CABG at each visit.

  • Cumulative incidence rate of Cardiac death at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Cardiac death at each visit.

  • Cumulative incidence rate of Death from any cause at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Death from any cause at each visit.

  • Cumulative incidence rate of Death from vascular cause at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Death from vascular cause at each visit.

  • Cumulative incidence rate of Acute MI at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Acute MI at each visit.

  • Cumulative incidence rate of Stroke at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Stroke at each visit.

  • Cumulative incidence rate of Stent thrombosis at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ] [ Designated as safety issue: No ]
    Cumulative incidence rate of Stent thrombosis(definite or probable) at each visit.


Estimated Enrollment: 3288
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ticagrelor
A Group which treated with Ticagrelor
Drug: Ticagrelor
Clopidogrel
A Group which treated with Clopidogrel
Drug: Clopidogrel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In this study, 3,288 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 and ticagrelor versus aspirin and clopidogrel during 11 months.

Criteria

Inclusion Criteria:

  1. Women and men, aged ≥ 18 y
  2. Patients with acute myocardial infarction (non-ST-elevation myocardial infarction or ST-elevation myocardial infarction) who take a medicine with ticagrelor for 30 days after undergo percutaneous coronary intervention with drug-eluting stent
  3. Patients who have previously given their informed consent for participation in the study
  4. Female patients, with childbearing potential who have committed to using adequate contraception

Exclusion Criteria:

  1. Cardiogenic shock
  2. Acitve internal bleeding, history of bleeding diathesis, or coagulopathy
  3. Gastrointestinal bleeding, genitourinary bleeding, hemoptysis, or vitreoretinal bleeding
  4. Major surgery within 6 weeks prior to screening
  5. Intracranial bleeding or structural abnormalities
  6. Anemia (hemoglobin < 10 g/dL) at the time of screening or Platelet count of less than 100,000/mm3 at the time of screening
  7. Oral anticoagulation that cannot be safely discontinued for the duration of the study
  8. Daily treatment with nonsteroidal anti-inflammatory drugs or clooxygenase-2 inhibitors
  9. Malignancy or life expectancy < 1 y
  10. Known severe hepatic dysfunction
  11. Symptomatic patients with sinus bradycardia or atrioventricular block
  12. Symptomatic patients with chronic obstructive pulmonary disease
  13. Intolerance of or allergy to aspirin, ticagrelor, or clopidogrel
  14. Treatment within the 3 months with an investigational drug or are presently enrolled in another drug or device study (except registry and observational study)
  15. Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding
  16. Patients who performed kidney transplantation or required dialysis
  17. A patient who has genetic disorder; for example galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
  18. Any other condition that may put the patient at risk or influence study results in the investigators' opinion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018055

Contacts
Contact: Ki-Bae Seung, Ph.D. 822-2258-1142 kbseung@catholic.ac.kr

Locations
Korea, Republic of
Seoul St.Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137701
Contact: KI-BAE SEUNG, M.D., Ph.D    822-2258-1142    kbseung@catholic.ac.kr   
Principal Investigator: KI-BAE SEUNG, M.D., Ph.D         
Sponsors and Collaborators
Ki-Bae Seung
Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Ki-Bae Seung, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02018055     History of Changes
Other Study ID Numbers: TALOS-AMI
Study First Received: December 17, 2013
Last Updated: June 16, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Clopidogrel
Ticagrelor
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014