Acute Myocardial InfarctionPhase 4NCT05210595
Optimal Dosage of Ticagrelor in Korean Patients With AMI
A Phase 4 study testing Clopidogrel 75 mg, Ticagrelor 60mg and Ticagrelor 45 mg in people with Acute Myocardial Infarction and Ticagrelor, run by Dong-A University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Ticagrelor
- What is being tested?
- Clopidogrel 75 mg, Ticagrelor 60mg and Ticagrelor 45 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
DongA University Hospital
Busan, 602-715
Moo Hyun Kim, M.D., +82-51-240-2976, kimmh@dau.ac.kr
Moo Hyun Kim, M.D.
About this study
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
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).
Read the 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.
- Conditions
- Acute Myocardial Infarction, Ticagrelor
- Being tested
- Clopidogrel 75 mg, Ticagrelor 60mg, Ticagrelor 45 mg
- Keywords
- Ticagrelor, De-escalation Strategy, Korean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 75 mgDrug
Also called Plavix 75 mg
75 mg/day as maintenance dose.
Ticagrelor 60mgDrug
Also called Brilinta 60 mg
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.
Ticagrelor 45 mgDrug
Also called Brilinta 45 mg
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 .
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Clopidogrel 75 mg/day as maintenance dose Receives: Drug: Clopidogrel 75 mg |
| Treatment group 1 | Experimental | De-escalation strategy dose receive ticagrelor 60 mg twice daily Receives: Drug: Ticagrelor 60mg |
| Treatment group 2 | Experimental | De-escalation strategy dose receive ticagrelor 45 mg twice daily Receives: Drug: Ticagrelor 45 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal platelet reactivity (OPR) rate
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)
Measured: At 1 month
Secondary outcomes (2)
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke
Measured: At 9 months
Bleeding events
BARC: Bleeding Academic Research Consortium (BARC ≥2).
Measured: At 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo Hyun Kim, Dong-A University
- Investigators
- Moo Hyun Kim, MD, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210595
- Sponsor's protocol ID
- HOPE-TAILOR 2
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05210595
- Acronym / sponsor ID
- HOPE-TAILOR 2
- Conditions
- Acute Myocardial Infarction, Ticagrelor
- Keywords
- Ticagrelor, De-escalation Strategy, Korean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: Clopidogrel 75 mgClopidogrel 75 mg/day as maintenance dose |
| Treatment group 1 | Experimental | Drug: Ticagrelor 60mgDe-escalation strategy dose receive ticagrelor 60 mg twice daily |
| Treatment group 2 | Experimental | Drug: Ticagrelor 45 mgDe-escalation strategy dose receive ticagrelor 45 mg twice daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel 75 mgAlso: Plavix 75 mg75 mg/day as maintenance dose. | Drug | Control group |
| Ticagrelor 60mgAlso: Brilinta 60 mgIn-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 60 twice daily after discharge or post PCI 1 week. | Drug | Treatment group 1 |
| Ticagrelor 45 mgAlso: Brilinta 45 mgIn-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 45 twice daily after discharge or post PCI 1 week . | Drug | Treatment group 2 |
Primary outcome
Optimal platelet reactivity (OPR) rate
Time frame: At 1 month
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)
2 secondary outcomes
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: At 9 months
Bleeding events
Time frame: At 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo Hyun Kim, MD principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel 75 mg, Ticagrelor 60mg and Ticagrelor 45 mg in people with Acute Myocardial Infarction and Ticagrelor, run by Dong-A University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moo Hyun Kim, MD (+82-51-240-2976, kimmh@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal platelet reactivity (OPR) rate (time frame: At 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.