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Prasugrel With Lower Dose - Loading Dose

Information source: Dong-A University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

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


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 inhibition



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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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


- 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

Page last updated: August 20, 2015

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