Acute Coronary SyndromesPhase 3PRAISE-GENENCT01641510
PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants
A Phase 3 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndromes, run by Dong-A University at 1 site in South Korea.
Trial summary
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Prasugrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Feb 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome
- Patients planned to undergo percutaneous transluminal coronary angioplasty
- Patients who agreed to the experimental plan which was permitted by IRB
Who cannot join
- Low body weight (< 50kg)
- History of stroke or transient ischemic attack
- History of upper gastrointestinal bleeding in recent 6 months
- Renal dysfunction defined by serum creatinine > 2.5 mg/dl
- Severe hepatic dysfunction defined by Child-Pugh criteria B or C
- Bleeding tendency
Show all 11Show fewer
- Anticoagulation treatment including warfarin
- Thrombocytopenia defined by platelet < 100,000/ml
- Anemia defined by hemoglobin < 10 g/dl
- Contraindication for antiplatelet treatment or anticoagulation treatment
- History of administer glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study Comparing the Efficacy and Safety of Prasugrel and Clopidogrel in Acute Coronary Syndrome Patients With CYP2C19 Polymorphism Who Undergo Percutaneous Coronary Intervention.
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.
Read the detailed description
Antiplatelet treatment is recommended worldwide for the secondary prevention and clopidogrel is an essential drug. But clopidogrel has limited value because of its pharmacodynamic interpatient variability and delayed onset time.
It is well known that patients who carry a common reduced-function CYP2C19 allele have a lower level of active metabolite of clopidogrel, diminished platelet inhibition, and furthermore, higher rate of major adverse cardiovascular events than noncarriers.
To achieve maximum plateau more rapidly and reduce the rate of high on-treatment platelet reactivity, higher loading dose of clopidogrel, up to 600 mg, is recommended. Although, however, the higher loading dose of clopidogrel, many patients still remain as non-responder.
Incidence of patients with clopidogrel resistance, especially CYP2C19*2 and *3, which encounter loss function, is higher in Eastern Asian peoples than Western peoples. Some studies report incidence rate of clopidogrel resistance in Eastern Asian peoples up to 99%.
However, the metabolism is not influenced by the presence of CYP2C19 genetic variation and prasugrel shows potent platelet inhibition. Although prasugrel exhibit potent platelet inhibition, recent reports describe the possible over inhibition of platelet especially in the East Asian people.
The investigators are going to compare the efficacy and safety of loading dose of prasugrel 30 mg which is lower than conventional loading dose followed by 5 mg/day which is also lower than conventional maintenance dose for 30 days and loading dose of clopidogrel 600 mg followed by 75 mg/day for 30 days.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Prasugrel, Clopidogrel
- Keywords
- reduced-function CYP2C19 allele, high platelet reactivity, clopidogrel, prasugrel
- 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.
PrasugrelDrug
Also called Effient
Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg
ClopidogrelDrug
Also called Plavix, Plavitor
Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Experimental | Loading and maintenance dose of prasugrel Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | Loading and maintenance dose of clopidogrel Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPR 1 day
High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI
Measured: 24 hours after PCI
Secondary outcomes (5)
MACE
Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)
Measured: 30 days
Bleeding
Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria
Measured: 30 days
HPRs
High platelet reactivity unit defined as platelet reactivity of 240u or more using VerifyNow method at 4 hours and 30 days after PCI
Measured: 4 hours after PCI, 30 days after PCI
HPR by VASP at 24 hours
HPR defined by VASP at 24 hours after PCI
Measured: 24 hours from PCI
HPR by VASP at 30 days
HPR by VASP at 30 days from PCI
Measured: 30 days from PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startOct 2013
- Primary completionOct 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 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, Director, Regional Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641510
- Sponsor's protocol ID
- PRAISE-GENE
- Acronym
- PRAISE-GENE
- Status last verified
- Feb 2019
- First submitted
- 2 Jul 2012
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Comparing the Efficacy and Safety of Prasugrel and Clopidogrel in Acute Coronary Syndrome Patients With CYP2C19 Polymorphism Who Undergo Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT01641510
- Acronym / sponsor ID
- PRAISE-GENE / PRAISE-GENE
- Conditions
- Acute Coronary Syndromes
- Keywords
- reduced-function CYP2C19 allele, high platelet reactivity, clopidogrel, prasugrel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 16 Jul 2012 (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.
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.
Detailed description
Antiplatelet treatment is recommended worldwide for the secondary prevention and clopidogrel is an essential drug. But clopidogrel has limited value because of its pharmacodynamic interpatient variability and delayed onset time.
It is well known that patients who carry a common reduced-function CYP2C19 allele have a lower level of active metabolite of clopidogrel, diminished platelet inhibition, and furthermore, higher rate of major adverse cardiovascular events than noncarriers.
To achieve maximum plateau more rapidly and reduce the rate of high on-treatment platelet reactivity, higher loading dose of clopidogrel, up to 600 mg, is recommended. Although, however, the higher loading dose of clopidogrel, many patients still remain as non-responder.
Incidence of patients with clopidogrel resistance, especially CYP2C19*2 and *3, which encounter loss function, is higher in Eastern Asian peoples than Western peoples. Some studies report incidence rate of clopidogrel resistance in Eastern Asian peoples up to 99%.
However, the metabolism is not influenced by the presence of CYP2C19 genetic variation and prasugrel shows potent platelet inhibition. Although prasugrel exhibit potent platelet inhibition, recent reports describe the possible over inhibition of platelet especially in the East Asian people.
The investigators are going to compare the efficacy and safety of loading dose of prasugrel 30 mg which is lower than conventional loading dose followed by 5 mg/day which is also lower than conventional maintenance dose for 30 days and loading dose of clopidogrel 600 mg followed by 75 mg/day for 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Experimental | Drug: PrasugrelLoading and maintenance dose of prasugrel |
| Clopidogrel | Active comparator | Drug: ClopidogrelLoading and maintenance dose of clopidogrel |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute coronary syndrome
- Patients planned to undergo percutaneous transluminal coronary angioplasty
- Patients who agreed to the experimental plan which was permitted by IRB
Key exclusion criteria (11 listed)
- Low body weight (< 50kg)
- History of stroke or transient ischemic attack
- History of upper gastrointestinal bleeding in recent 6 months
- Renal dysfunction defined by serum creatinine > 2.5 mg/dl
- Severe hepatic dysfunction defined by Child-Pugh criteria B or C
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 |
|---|---|---|
| PrasugrelAlso: EffientLoading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg | Drug | Prasugrel |
| ClopidogrelAlso: Plavix, PlavitorLoading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg | Drug | Clopidogrel |
Primary outcome
HPR 1 day
Time frame: 24 hours after PCI
High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI
5 secondary outcomes
MACE
Time frame: 30 days
Bleeding
Time frame: 30 days
HPRs
Time frame: 4 hours after PCI, 30 days after PCI
HPR by VASP at 24 hours
Time frame: 24 hours from PCI
HPR by VASP at 30 days
Time frame: 30 days from PCI
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 11 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Coronary Syndromes
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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
Director, Regional Clinical Trial Center
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 Prasugrel and Clopidogrel in people with Acute Coronary Syndromes, 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 11 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 11 Feb 2019. 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?
HPR 1 day (time frame: 24 hours after PCI). 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 11 Feb 2019.