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

• Status: Completed
• Trial end date: 2021-01-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ki-Bae Seung; The Catholic University of Korea
• Collaborator: Chonnam National University Hospital
• Treatments: Aspirin; Clopidogrel; Ticagrelor; Ticlopidine

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