NCT02018055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,590

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

6.9 years

First QC Date

December 17, 2013

Last Update Submit

March 31, 2021

Conditions

Acute Myocardial Infarction

Keywords

dual antiplaltelet therapyDeescalation of P2Y12 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of Net adverse clinical event

    Composite endpoint of MACCE (CV death, MI, or stroke) + BARC bleeding (type 2, 3 or 5) between 1 and 12 months after AMI

    1 month to 12months after AMI

Secondary Outcomes (9)

  • Cumulative incidence of BARC bleeding (type 2, 3, or 5)

    1 month to 12months after AMI

  • Cumulative incidence of Composite endpoint of MACCE (CV death, MI, or stroke) + BARC bleeding (type 3, 5)

    1 month to 12months after AMI

  • Cumulative incidence of Composite endpoint of MACCE (CV death, MI, or stroke)

    1 month to 12months after AMI

  • Cumulative incidence of All-cause death

    1 month to 12months after AMI

  • Cumulative incidence of CV death

    1 month to 12months after AMI

  • +4 more secondary outcomes

Study Arms (2)

Aspirin+Ticagrelor

ACTIVE COMPARATOR

A Group treated with Aspirin+Ticagrelor

Drug: Aspirin+Ticagrelor

Aspirin+Clopidogrel

EXPERIMENTAL

A Group treated with Aspirin+Clopidogrel

Drug: Aspirin+Clopidogrel

Interventions

Aspirin+TicagrelorDRUG

Aspirin+ Ticagrelor after 1month of standard DAPT (Aspirin+Ticagrelor)

Aspirin+Ticagrelor
Aspirin+ClopidogrelDRUG

Aspirin+ Clopidogrel after 1month of standard DAPT (Aspirin+Ticagrelor)

Aspirin+Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject should meet all of the following criteria.
  • Age \>= 18 years
  • 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.
  • Female patients with childbearing potential who agree to mandatory pregnancy test and have committed to using adequate contraception
  • 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

You may not qualify if:

  • Subject should be excluded if they apply to any of the following criteria.
  • Cardiogenic shock
  • Active internal bleeding, bleeding diathesis, or coagulopathy
  • Gastrointestinal bleeding or genitourinary bleeding, hemoptysis, or vitreous hemorrhage within 2 months
  • Major surgery within 6 weeks
  • History of intracranial bleeding, intracranial neoplasm, intracranial arteriovenous malformation, or intracranial aneurysm
  • Anemia (hemoglobin \< 10 g/dL) or platelet count of less than 100,000/mm3 at the time of screening
  • Concomitant treatment with oral anticoagulant agent (vitamin-K antagonists or novel oral anticoagulants such as dabigatran, rivaroxaban, apixaban, or edoxaban)
  • Daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 inhibitors
  • Malignancy or life expectancy of less than one year
  • Moderate or severe hepatic dysfunction (Child Pugh B or C)
  • 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)
  • Symptomatic patients with chronic obstructive pulmonary disease (Medical research council grade \>=3)
  • Intolerance of or allergy to aspirin, ticagrelor or clopidogrel
  • Subjects who are under renal replacement therapy due to end-stage renal disease or who have history of kidney transplantation
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, 137701, South Korea

Location

Related Publications (4)

  • Bu S, Kim CJ, Lim S, Jang J, Park MW, Choi IJ, Moon D, Hwang BH, Choo EH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Chang K; TALOS-AMI investigators. BMI and Deescalation From Ticagrelor to Clopidogrel in Patients With Acute Myocardial Infarction: A Post Hoc Analysis of the TALOS-AMI Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461916. doi: 10.1001/jamanetworkopen.2024.61916.

    PMID: 40014346DERIVED

  • Kim SH, Shin S, Choo EH, Choi IJ, Lim S, Moon D, Kim CJ, Park MW, Kim MC, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Ahn Y, Chang K; TALOS-AMI investigators. Clinical Impact of Dyspnea after Ticagrelor Treatment and the Effect of Switching to Clopidogrel in Patients with Myocardial Infarction. Thromb Haemost. 2024 Dec;124(12):1152-1161. doi: 10.1055/a-2299-4537. Epub 2024 Apr 4.

    PMID: 38574757DERIVED

  • Choo EH, Choi IJ, Lim S, Moon D, Kim CJ, Park MW, Kim MC, Hwang BH, Lee KY, Seok Choi Y, Kim HY, Yoo KD, Jeon DS, Ahn Y, Chang K; TALOS-AMI Investigators. Prognosis and the Effect of De-Escalation of Antiplatelet Therapy After Nuisance Bleeding in Patients With Myocardial Infarction. Circ Cardiovasc Interv. 2022 Dec;15(12):e012157. doi: 10.1161/CIRCINTERVENTIONS.122.012157. Epub 2022 Nov 16.

    PMID: 36382599DERIVED

  • Kim CJ, Park MW, Kim MC, Choo EH, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Shin ES, Jeong YH, Seung KB, Jeong MH, Yim HW, Ahn Y, Chang K; TALOS-AMI investigators. Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial. Lancet. 2021 Oct 9;398(10308):1305-1316. doi: 10.1016/S0140-6736(21)01445-8.

    PMID: 34627490DERIVED

Study Officials

  • Kiyuk Chang, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 23, 2013

Study Start

February 14, 2014

Primary Completion

January 21, 2021

Study Completion

January 21, 2021

Last Updated

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)