Acute Coronary SyndromePhase 3NCT02944123
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)
A Phase 3 study testing Clopidogrel 75 mg, Prasugrel 5 mg and Ticagrelor 45 mg in people with Acute Coronary Syndrome, run by Dong-A University at 1 site in South Korea.
Trial summary
East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are 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 Coronary Syndrome
- What is being tested?
- Clopidogrel 75 mg, Prasugrel 5 mg 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
- Sep 2016to Jun 2020
- Phase
- Phase 3
- 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 coronary syndrome undergoing primary PCI.
- Patients receive DAPT (conventional dose of P2Y12 inhibitors+aspirin) at least 1 month.
- Patients provide written informed consent prior to enrollment.
Who cannot join
- Low body weight (<60kg).
- History of transient ischemic attack or stroke.
- History of upper gastrointestinal bleeding in recent 6 months.
- Renal dysfunction defined as serum creatinine > 2.5 mg/dl
- Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
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- Bleeding tendency.
- Thrombocytopenia defined by platelet < 100,000/ml.
- Anemia defined by hemoglobin < 10 g/dl.
- 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.
- Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
- Contraindication for study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Prospective Study Exploring Half Dose of Prasugrel and Ticagrelor in Platelet Response After Acute Coronary Syndromes
East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
Read the detailed description
In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been strong recommendations for management of patients with ACS undergoing (PCI). These drugs 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 Coronary Syndrome
- Being tested
- Clopidogrel 75 mg, Prasugrel 5 mg, Ticagrelor 45 mg
- Keywords
- Half dose, Newer oral P2Y12 receptor inhibitors, Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
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
Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.
Prasugrel 5 mgDrug
Also called Effient 5 mg
Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.
Ticagrelor 45 mgDrug
Also called Brilinta 45 mg
Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel 75 mg | Other | Clopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose. Receives: Drug: Clopidogrel 75 mg |
| Prasugrel 5 mg | Experimental | Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment. Receives: Drug: Prasugrel 5 mg |
| Ticagrelor 45 mg | Experimental | Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment. 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) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)
Measured: At post-PCI 3 months.
Secondary outcomes (3)
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE: composite of cardiac death, non-fatal myocardial infarction, repeat revascularization and stroke
Measured: Post-PCI 6 months.
Bleeding events
BARC: Bleeding Academic Research Consortium (BARC ≥2).
Measured: Post-PCI 6 months.
Drug side effects
Dyspnea or ventricular pauses ≥3 sec
Measured: Post-PCI 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
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
- NCT02944123
- Sponsor's protocol ID
- HOPE-TAILOR
- Status last verified
- Aug 2020
- First submitted
- 24 Oct 2016
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Goto S, Huang CH, Park SJ, Emanuelsson H, Kimura T. Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study. Circ J. 2015;79(11):2452-60. doi: 10.1253/circj.CJ-15-0112. Epub 2015 Sep 16.
PubMed 26376600
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Prospective Study Exploring Half Dose of Prasugrel and Ticagrelor in Platelet Response After Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT02944123
- Acronym / sponsor ID
- HOPE-TAILOR
- Conditions
- Acute Coronary Syndrome
- Keywords
- Half dose, Newer oral P2Y12 receptor inhibitors, Acute coronary syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 25 Oct 2016 (estimated)
- 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 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
Detailed description
In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been strong recommendations for management of patients with ACS undergoing (PCI). These drugs 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
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel 75 mg | Other | Drug: Clopidogrel 75 mgClopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose. |
| Prasugrel 5 mg | Experimental | Drug: Prasugrel 5 mgLoading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment. |
| Ticagrelor 45 mg | Experimental | Drug: Ticagrelor 45 mgLoading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment. |
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 coronary syndrome undergoing primary PCI.
- Patients receive DAPT (conventional dose of P2Y12 inhibitors+aspirin) at least 1 month.
- Patients provide written informed consent prior to enrollment.
Key exclusion criteria (12 listed)
- Low body weight (<60kg).
- History of transient ischemic attack or stroke.
- History of upper gastrointestinal bleeding in recent 6 months.
- Renal dysfunction defined as serum creatinine > 2.5 mg/dl
- Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit
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 mgClopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose. | Drug | Clopidogrel 75 mg |
| Prasugrel 5 mgAlso: Effient 5 mgLoading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment. | Drug | Prasugrel 5 mg |
| Ticagrelor 45 mgAlso: Brilinta 45 mgLoading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment. | Drug | Ticagrelor 45 mg |
Primary outcome
Optimal platelet reactivity (OPR) rate
Time frame: At post-PCI 3 months.
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)
3 secondary outcomes
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: Post-PCI 6 months.
Bleeding events
Time frame: Post-PCI 6 months.
Drug side effects
Time frame: Post-PCI 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Background: PubMed 26376600Goto S, Huang CH, Park SJ, Emanuelsson H, Kimura T. Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study. Circ J. 2015;79(11):2452-60. doi: 10.1253/circj.CJ-15-0112. Epub 2015 Sep 16.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Clopidogrel 75 mg, Prasugrel 5 mg and Ticagrelor 45 mg in people with Acute Coronary Syndrome, 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 12 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: finished, as of the sponsor's last update on 20 Aug 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal platelet reactivity (OPR) rate (time frame: At post-PCI 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02944123, which also lists 1 linked publication.
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 20 Aug 2020.