Acute Coronary SyndromePREP-TAMINCT04768582
Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients
A study testing P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay in people with Acute Coronary Syndrome and Hemorrhage, run by Feng Yuan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Prasugrel has a faster onset of action and greater platelet inhibition with less inter-individual response variability than clopidogrel. Japan and Taiwan are the only two nations where adjusted/Asian dose of prasugrel (loading dose (LD)/maintenance (MD): 20/3.75 mg) was approved for clinical use. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Hemorrhage, Treatment Side Effects
- What is being tested?
- P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2020to 1 May 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>=20
- Mentally competent to provide an informed consent.
- A person being diagnosed with acute coronary syndrome and arranged for a percutaneous coronary intervention.
Who cannot join
- A history of hemorrhagic stroke at any time in the past.
- Active internal bleeding or has a history of a bleeding disorder (i.e. hemophilia).
- Severe liver disease; for example, cirrhosis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Feng Yuan Hospital
Taichung, 42055
ChenRong Tsao, M.D., +886425271180 ext. 5280, tsaodr@gmail.com
About this study
Official title: Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study
Prasugrel has a faster onset of action and greater platelet inhibition with less inter-individual response variability than clopidogrel. Japan and Taiwan are the only two nations where adjusted/Asian dose of prasugrel (loading dose (LD)/maintenance (MD): 20/3.75 mg) was approved for clinical use. However, there is no data regarding the effectiveness of adjusted dose of prasugrel on platelet reactivity in Taiwanese patients with acute coronary syndrome (ACS). This study aim to evaluate the pharmacodynamic of the Asian dose prasugrel on the platelet reactivity after percutaneous coronary intervention (PCI) for patients with ACS.
Read the detailed description
Rationale and Background Prasugrel provides more potent and rapid platelet inhibition compared to Clopidogrel.
Rapid and effective inhibition of the platelet P2Y12 receptor is of pivotal importance in patients with AMI who undergo PCI.
Prasugrel (60 mg loading and 10 mg/day maintenance dose) is a new generation P2Y12 inhibitor that achieves greater and faster platelet inhibition comparing with clopidogrel in patients undergoing PCI.
As revealed by 2 head-to-head studies, reducing Prasugrel dosages to 20/3.75 LD/MD (mg) was still efficacious but led to less bleeding events than the original 60/10 LD/MD (mg).
In TRITON-TIMI 38 trial, prasugrel was associated with not only significantly less ischemic events but also more non-CABG TIMI major bleeding, as compared to Clopidogrel.
In the PRASFIT-ACS study from Japan (20 mg loading and 3.75 mg/day maintenance dose), prasugrel was associated with a 23% reduction of MACE and the incidence of non-CABG major bleeding was similar to clopidogrel.
There is NO data regarding the effectiveness of Japanese loading dose of prasugrel on platelet reactivity in Taiwanese patients with AMI.
This study use PRU for efficacy and ISTH major bleeding for safety evaluations; the anticipated results are prompt and effective platelet inhibition as well as comparably low bleeding rate.
- Conditions
- Acute Coronary Syndrome, Hemorrhage, Treatment Side Effects
- Being tested
- P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay
- Keywords
- Acute Coronary Syndrome, Prasugrel, VerifyNow-P2Y12 assay
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assayDiagnostic test
The efficacy endpoint was platelet reactivity, of which was serially assessed using the VerifyNow-P2Y12 assay and the results were expressed as P2Y12-reaction-units (PRU).
| Study group | Role | What they receive |
|---|---|---|
| Efient group | Experimental | ACS patients who received oral Prasugrel after coronary angiography been done Receives: Diagnostic Test: P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet reactivity (PRU) after loading of prasugrel at 12 hours
PRU 12 hours after a loading dose
Measured: 12 hours
Secondary outcomes (4)
platelet reactivity (PRU) after loading of prasugrel at 1 hour
PRU 1 hour after a loading dose
Measured: one hour
platelet reactivity (PRU) after loading of prasugrel at 3 hours
PRU 3 hours after a loading dose
Measured: 3 hours
platelet reactivity (PRU) after loading of prasugrel at 48 hours
PRU 48 hours after a loading dose
Measured: 48 hours
ISTH Major bleeding
the definition recommended by the International Society on Thrombosis and Haemostasis (ISTH) defines major bleeding as fatal bleeding; symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular resulting in vision changes, retroperitoneal, intraarticular, pericardial
Measured: day 7 after a loading dose of prasugrel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 May 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Yuan Hospital, Ministry of Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Cheng-Hsin General Hospital
- Responsible party
- Principal investigator, Chen-Rong, Tsao M.D., Feng Yuan Hospital, Ministry of Health and Welfare
- Investigators
- CHEN RONG TSAO, M.D., Principal investigator, Feng Yuang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768582
- Sponsor's protocol ID
- FYHIRB109001
- Acronym
- PREP-TAMI
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study
- ClinicalTrials.gov ID
- NCT04768582
- Acronym / sponsor ID
- PREP-TAMI / FYHIRB109001
- Conditions
- Acute Coronary Syndrome, Hemorrhage, Treatment Side Effects
- Keywords
- Acute Coronary Syndrome, Prasugrel, VerifyNow-P2Y12 assay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Feng Yuan Hospital, Ministry of Health and WelfareOther government
- Collaborators
- Cheng-Hsin General Hospital
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 24 Feb 2021 (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.
Prasugrel has a faster onset of action and greater platelet inhibition with less inter-individual response variability than clopidogrel. Japan and Taiwan are the only two nations where adjusted/Asian dose of prasugrel (loading dose (LD)/maintenance (MD): 20/3.75 mg) was approved for clinical use. However, there is no data regarding the effectiveness of adjusted dose of prasugrel on platelet reactivity in Taiwanese patients with acute coronary syndrome (ACS). This study aim to evaluate the pharmacodynamic of the Asian dose prasugrel on the platelet reactivity after percutaneous coronary intervention (PCI) for patients with ACS.
Detailed description
Rationale and Background Prasugrel provides more potent and rapid platelet inhibition compared to Clopidogrel.
Rapid and effective inhibition of the platelet P2Y12 receptor is of pivotal importance in patients with AMI who undergo PCI.
Prasugrel (60 mg loading and 10 mg/day maintenance dose) is a new generation P2Y12 inhibitor that achieves greater and faster platelet inhibition comparing with clopidogrel in patients undergoing PCI.
As revealed by 2 head-to-head studies, reducing Prasugrel dosages to 20/3.75 LD/MD (mg) was still efficacious but led to less bleeding events than the original 60/10 LD/MD (mg).
In TRITON-TIMI 38 trial, prasugrel was associated with not only significantly less ischemic events but also more non-CABG TIMI major bleeding, as compared to Clopidogrel.
In the PRASFIT-ACS study from Japan (20 mg loading and 3.75 mg/day maintenance dose), prasugrel was associated with a 23% reduction of MACE and the incidence of non-CABG major bleeding was similar to clopidogrel.
There is NO data regarding the effectiveness of Japanese loading dose of prasugrel on platelet reactivity in Taiwanese patients with AMI.
This study use PRU for efficacy and ISTH major bleeding for safety evaluations; the anticipated results are prompt and effective platelet inhibition as well as comparably low bleeding rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efient group | Experimental | Diagnostic Test: P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assayACS patients who received oral Prasugrel after coronary angiography been done |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>=20
- Mentally competent to provide an informed consent.
- A person being diagnosed with acute coronary syndrome and arranged for a percutaneous coronary intervention.
Key exclusion criteria (3 listed)
- A history of hemorrhagic stroke at any time in the past.
- Active internal bleeding or has a history of a bleeding disorder (i.e. hemophilia).
- Severe liver disease; for example, cirrhosis.
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 |
|---|---|---|
| P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assayThe efficacy endpoint was platelet reactivity, of which was serially assessed using the VerifyNow-P2Y12 assay and the results were expressed as P2Y12-reaction-units (PRU). | Diagnostic test | Efient group |
Primary outcome
platelet reactivity (PRU) after loading of prasugrel at 12 hours
Time frame: 12 hours
PRU 12 hours after a loading dose
4 secondary outcomes
platelet reactivity (PRU) after loading of prasugrel at 1 hour
Time frame: one hour
platelet reactivity (PRU) after loading of prasugrel at 3 hours
Time frame: 3 hours
platelet reactivity (PRU) after loading of prasugrel at 48 hours
Time frame: 48 hours
ISTH Major bleeding
Time frame: day 7 after a loading dose of prasugrel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- 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.
CHEN RONG TSAO, M.D. principal investigator
Feng Yuang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay in people with Acute Coronary Syndrome and Hemorrhage, run by Feng Yuan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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 3 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 26 Feb 2021. 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 Taiwan. 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.
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 Ms. Hao-Yien Pan (+88625271180 ext. 2400, shine75726@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet reactivity (PRU) after loading of prasugrel at 12 hours (time frame: 12 hours). 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 26 Feb 2021.