Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
43 participants
INTERVENTIONAL
2011-12-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants
NCT01641510
Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention
NCT01609647
Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI
NCT01135667
Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease
NCT01107912
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
NCT01463150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clopidogrel 600 mg
Patients administer conventional loading dose of clopidogrel 600 mg as active comparators.
Clopidogrel 600 mg
Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel
Prasugrel 30 mg
Patients administer lower loading dose of prasugrel 30 mg.
Prasugrel 30 mg
Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.
Prasugrel 60 mg
Patients administer conventional loading dose of prasugrel 60 mg as active comparators.
Prasugrel 60 mg
Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clopidogrel 600 mg
Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel
Prasugrel 30 mg
Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.
Prasugrel 60 mg
Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable or unstable angina
* Planned to undergo elective coronary angiography
Exclusion Criteria
* Intracranial neoplasm
* Uncontrolled malignant disease
* History of antiplatelet or anticoagulation treatment within 1 month
* Contraindication to the study drug
* Bleeding diathesis
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Moo Hyun Kim
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
DongA University Hospital
Busan, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRELOAD-LD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.