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Optimal Dosage of Ticagrelor in Korean Patients With AMI

Primary Purpose

Acute Myocardial Infarction, Ticagrelor

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clopidogrel 75 mg

Ticagrelor 60mg

Ticagrelor 45 mg

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Ticagrelor, De-escalation Strategy, Korean

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients present with acute myocardial infarction undergoing PCI.
Patients receiving ticagrelor; Male or female gender; Age 20-75 years.
Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

Low body weight (<60kg).
History of hemorrhagic stroke.
History of upper gastrointestinal bleeding in recent 6 months.
Bleeding tendency.
Thrombocytopenia defined by platelet < 100,000/ml.
Anemia defined by hemoglobin < 10 g/dl.
Renal dysfunction defined as serum creatinine > 2.5 mg/dl.
Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit.
Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.

Sites / Locations

DongA University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Control group

Treatment group 1

Treatment group 2

Arm Description

Clopidogrel 75 mg/day as maintenance dose

De-escalation strategy dose receive ticagrelor 60 mg twice daily

De-escalation strategy dose receive ticagrelor 45 mg twice daily

Outcomes

Primary Outcome Measures

Optimal platelet reactivity (OPR) rate

OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)

Secondary Outcome Measures

Major adverse cardiac and cerebrovascular events (MACCE)

MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke

Bleeding events

BARC: Bleeding Academic Research Consortium (BARC ≥2).

Full Information

NCT ID

NCT05210595

First Posted

January 14, 2022

Last Updated

January 14, 2022

Sponsor

Dong-A University

1. Study Identification

Unique Protocol Identification Number

NCT05210595

Brief Title

Optimal Dosage of Ticagrelor in Korean Patients With AMI

Official Title

The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).

Detailed Description

In recent years, newer oral P2Y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with AMI undergoing (PCI). This drug provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction, Ticagrelor

Keywords

Ticagrelor, De-escalation Strategy, Korean

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Experimental

Arm Description

Clopidogrel 75 mg/day as maintenance dose

Arm Title

Treatment group 1

Arm Type

Experimental

Arm Description

De-escalation strategy dose receive ticagrelor 60 mg twice daily

Arm Title

Treatment group 2

Arm Type

Experimental

Arm Description

De-escalation strategy dose receive ticagrelor 45 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Clopidogrel 75 mg

Other Intervention Name(s)

Plavix 75 mg

Intervention Description

75 mg/day as maintenance dose.

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 60mg

Other Intervention Name(s)

Brilinta 60 mg

Intervention Description

In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 60 twice daily after discharge or post PCI 1 week.

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 45 mg

Other Intervention Name(s)

Brilinta 45 mg

Intervention Description

In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 45 twice daily after discharge or post PCI 1 week .

Primary Outcome Measure Information:

Title

Optimal platelet reactivity (OPR) rate

Description

OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)

Time Frame

At 1 month

Secondary Outcome Measure Information:

Title

Major adverse cardiac and cerebrovascular events (MACCE)

Description

MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke

Time Frame

At 9 months

Title

Bleeding events

Description

BARC: Bleeding Academic Research Consortium (BARC ≥2).

Time Frame

At 9 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients present with acute myocardial infarction undergoing PCI. Patients receiving ticagrelor; Male or female gender; Age 20-75 years. Patients provide written informed consent prior to enrollment. Exclusion Criteria: Low body weight (<60kg). History of hemorrhagic stroke. History of upper gastrointestinal bleeding in recent 6 months. Bleeding tendency. Thrombocytopenia defined by platelet < 100,000/ml. Anemia defined by hemoglobin < 10 g/dl. Renal dysfunction defined as serum creatinine > 2.5 mg/dl. Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit. Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection). Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moo Hyun Kim, MD

Phone

+82-51-240-2976

kimmh@dau.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moo Hyun Kim, MD

Organizational Affiliation

Dong-A University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

DongA University Hospital

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moo Hyun Kim, M.D.

Phone

+82-51-240-2976

kimmh@dau.ac.kr

First Name & Middle Initial & Last Name & Degree

Moo Hyun Kim, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Optimal Dosage of Ticagrelor in Korean Patients With AMI

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