Coronary Artery DiseasePhase 3PRELOAD-LDNCT02070159
Prasugrel With Lower Dose - Loading Dose
A Phase 3 study testing Clopidogrel 600 mg, Prasugrel 30 mg and Prasugrel 60 mg in people with Coronary Artery Disease, run by Dong-A University at 1 site in South Korea.
Trial summary
Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel 600 mg, Prasugrel 30 mg and Prasugrel 60 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Jan 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 80 years
- Stable or unstable angina
- Planned to undergo elective coronary angiography
Who cannot join
- Previous history of transient ischemic attack or stroke
- Intracranial neoplasm
- Uncontrolled malignant disease
- History of antiplatelet or anticoagulation treatment within 1 month
- Contraindication to the study drug
- Bleeding diathesis
Show all 11Show fewer
- Hemoglobin < 10 g/dl
- Platelet count < 100,000/mm3
- Significant renal insufficiency (glomerular filtration rate <60 mL/min/1.73 m2)
- Significant hepatic impairment (Serum liver enzyme or bilirubin > 3 times normal limit)
- Body weight < 50 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lower Loading Dose of Prasugrel Compared With Conventional Loading Dose of Clopidogrel and Prasugrel in Korean Coronary Artery Disease Patients Undergoing Coronary Angiography
Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.
Read the detailed description
Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in coronary artery disease patients, clopidogrel has several limitations. It has delayed onset of peak concentration and pharmacodynamic inter-patient response variability resulting in high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with adverse cardiovascular outcomes.
Prasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic response to prasugrel in East Asian ethnicities.
In addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of prasugrel in healthy Korean subjects.
The investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary artery disease patients undergoing elective coronary angiography.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel 600 mg, Prasugrel 30 mg, Prasugrel 60 mg
- Keywords
- coronary artery disease, prasugrel, platelet function tests
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 600 mgDrug
Also called Plavix 600 mg
Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel
Prasugrel 30 mgDrug
Also called Effient 30 mg
Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.
Prasugrel 60 mgDrug
Also called Effient 60 mg
Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel 600 mg | Active comparator | Patients administer conventional loading dose of clopidogrel 600 mg as active comparators. Receives: Drug: Clopidogrel 600 mg |
| Prasugrel 30 mg | Experimental | Patients administer lower loading dose of prasugrel 30 mg. Receives: Drug: Prasugrel 30 mg |
| Prasugrel 60 mg | Active comparator | Patients administer conventional loading dose of prasugrel 60 mg as active comparators. Receives: Drug: Prasugrel 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Platelet reactivity was measured using traditional light transmission aggregometry (LTA), VerifyNow (Accumetrics, San Diego, CA, USA), and multiple electrode aggregometry (MEA, Dynabyte Medical, Munich, Germany).
The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).
Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
Secondary outcomes (5)
Percent inhibition
Percent inhibition is calculated using the following fomula: % inhibition = [(baseline reactivity unit - peak reactivity unit) / baseline reactivity unit] × 100.
Percent inhibition is measured at the time of peak platelet inhibition. The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).
Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
HPR
The high platelet reactivity (HPR) was defined as the results of LTA ≥ 48% or ≥ 55%, PRU ≥ 242 or ≥ 275, and result of MEA assay ≥ 37 U or 54 U at the time of peak platelet inhibition The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).
Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
LPR
The low platelet reactivity (LPR) was defined as LTA < 12, PRU < 85, MEA < 19 at the time of peak platelet inhibition.
The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).
Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
Bleeding event
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on BARC and ACUITY criteria.
Measured: 30 days after study drug administration
Adverse reaction
Any adverse reaction related to study drug.
Measured: 30 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionJan 2013
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 Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 43 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070159
- Sponsor's protocol ID
- PRELOAD-LD
- Acronym
- PRELOAD-LD
- Status last verified
- Feb 2014
- First submitted
- 8 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim MH, Zhang HZ, Jung DK. Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers. Circ J. 2013;77(5):1253-9. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.
PubMed 23363643
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Loading Dose of Prasugrel Compared With Conventional Loading Dose of Clopidogrel and Prasugrel in Korean Coronary Artery Disease Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT02070159
- Acronym / sponsor ID
- PRELOAD-LD / PRELOAD-LD
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, prasugrel, platelet function tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Feb 2014 (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.
Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.
Detailed description
Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in coronary artery disease patients, clopidogrel has several limitations. It has delayed onset of peak concentration and pharmacodynamic inter-patient response variability resulting in high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with adverse cardiovascular outcomes.
Prasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic response to prasugrel in East Asian ethnicities.
In addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of prasugrel in healthy Korean subjects.
The investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary artery disease patients undergoing elective coronary angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel 600 mg | Active comparator | Drug: Clopidogrel 600 mgPatients administer conventional loading dose of clopidogrel 600 mg as active comparators. |
| Prasugrel 30 mg | Experimental | Drug: Prasugrel 30 mgPatients administer lower loading dose of prasugrel 30 mg. |
| Prasugrel 60 mg | Active comparator | Drug: Prasugrel 60 mgPatients administer conventional loading dose of prasugrel 60 mg as active comparators. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 and 80 years
- Stable or unstable angina
- Planned to undergo elective coronary angiography
Key exclusion criteria (11 listed)
- Previous history of transient ischemic attack or stroke
- Intracranial neoplasm
- Uncontrolled malignant disease
- History of antiplatelet or anticoagulation treatment within 1 month
- Contraindication to the study drug
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 600 mgAlso: Plavix 600 mgPatients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel | Drug | Clopidogrel 600 mg |
| Prasugrel 30 mgAlso: Effient 30 mgPatients administer 30 mg of prasugrel as lower loading dose of prasugrel. | Drug | Prasugrel 30 mg |
| Prasugrel 60 mgAlso: Effient 60 mgPatients take 60 mg of prasugrel as conventional loading dose of prasugrel. | Drug | Prasugrel 60 mg |
Primary outcome
Platelet reactivity
Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
Platelet reactivity was measured using traditional light transmission aggregometry (LTA), VerifyNow (Accumetrics, San Diego, CA, USA), and multiple electrode aggregometry (MEA, Dynabyte Medical, Munich, Germany). The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).
5 secondary outcomes
Percent inhibition
Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
HPR
Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
LPR
Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
Bleeding event
Time frame: 30 days after study drug administration
Adverse reaction
Time frame: 30 days after study drug administration
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 25 Feb 2014.
- Background: PubMed 23363643Kim MH, Zhang HZ, Jung DK. Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers. Circ J. 2013;77(5):1253-9. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 600 mg, Prasugrel 30 mg and Prasugrel 60 mg in people with Coronary Artery Disease, 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 25 Feb 2014. 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?
Platelet reactivity (time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)). 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 NCT02070159, 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 25 Feb 2014.