Prasugrel With Lower Dose - Loading Dose
Information source: Dong-A University
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Condition(s) targeted: Coronary Artery Disease
Intervention: Clopidogrel 600 mg (Drug); Prasugrel 30 mg (Drug); Prasugrel 60 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Dong-A University
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. The investigators compared the effect of lower loading
dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Platelet reactivity
Secondary outcome: Percent inhibitionHPR LPR Bleeding event Adverse reaction
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients between 18 and 80 years
- Stable or unstable angina
- Planned to undergo elective coronary angiography
Exclusion Criteria:
- 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
- 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
Locations and Contacts
DongA University Hospital, Busan 602-715, Korea, Republic of
Additional Information
Related 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. Epub 2013 Jan 30.
Starting date: December 2011
Last updated: February 21, 2014
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