Prasugrel With Lower Dose - Loading Dose

Last updated: February 21, 2014
Sponsor: Dong-A University
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Myocardial Ischemia

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT02070159
PRELOAD-LD
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients between 18 and 80 years

  • Stable or unstable angina

  • Planned to undergo elective coronary angiography

Exclusion

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 normallimit)

  • Body weight < 50 kg

Study Design

Total Participants: 43
Study Start date:
December 01, 2011
Estimated Completion Date:
January 31, 2013

Study 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.

Connect with a study center

  • DongA University Hospital

    Busan, 602-715
    Korea, Republic of

    Site Not Available

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