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Trial record 51 of 360 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02018055
Recruitment Status : Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : May 19, 2020
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 Not Applicable

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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 2014
Actual Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

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 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 ]
    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 :
  1. Cumulative incidence rate of MACCE(CV death, MI, stroke) at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of MACCE(CV death, MI, stroke) at each visit.

  2. 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 ]
    Cumulative incidence rate of Bleedings according to the BARC definitions (type 2, 3 or 5) at each visit.

  3. Cumulative incidence rate of Ischemia Driven Revascularization including PCI or CABG at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Ischemia Driven Revascularization including PCI or CABG at each visit.

  4. Cumulative incidence rate of Cardiac death at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Cardiac death at each visit.

  5. Cumulative incidence rate of Death from any cause at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Death from any cause at each visit.

  6. Cumulative incidence rate of Death from vascular cause at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Death from vascular cause at each visit.

  7. Cumulative incidence rate of Acute MI at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Acute MI at each visit.

  8. Cumulative incidence rate of Stroke at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Stroke at each visit.

  9. Cumulative incidence rate of Stent thrombosis at each visit. [ Time Frame: 1 month to 3months, 6months, 12months ]
    Cumulative incidence rate of Stent thrombosis(definite or probable) at each visit.



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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:

  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

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
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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: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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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Aspirin
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
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