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Completed

NCT Number: NCT02070159

Prasugrel With Lower Dose - Loading Dose

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DongA University Hospital

Busan, 602-715, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clopidogrel 600 mg

Drug

Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel

Other names: Plavix 600 mg

Prasugrel 30 mg

Drug

Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.

Other names: Effient 30 mg

prasugrel 60 mg

Drug

Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.

Other names: Effient 60 mg

Primary outcomes

  1. 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).

Secondary outcomes

  1. Percent inhibition

    Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

    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).

  2. HPR

    Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

    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).

  3. LPR

    Time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

    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).

  4. Bleeding event

    Time frame: 30 days after study drug administration

    Any event related to bleeding including access site bleeding and peri-procedural bleeding based on BARC and ACUITY criteria.

  5. Adverse reaction

    Time frame: 30 days after study drug administration

    Any adverse reaction related to study drug.

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study 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

Acronym: PRELOAD-LD

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 25, 2014
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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