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

December 17, 2013
June 16, 2014
January 2014
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02018055 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Acute Myocardial Infarction
  • Drug: Ticagrelor
  • Drug: Clopidogrel
  • Ticagrelor
    A Group which treated with Ticagrelor
    Intervention: Drug: Ticagrelor
  • Clopidogrel
    A Group which treated with Clopidogrel
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3288
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ki-Bae Seung, Ph.D. 822-2258-1142 kbseung@catholic.ac.kr
Korea, Republic of
 
NCT02018055
TALOS-AMI
Yes
Ki-Bae Seung, The Catholic University of Korea
Ki-Bae Seung
Chonnam National University Hospital
Not Provided
The Catholic University of Korea
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP