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Prasugrel With Lower Dose - Loading Dose (PRELOAD-LD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070159
First Posted: February 25, 2014
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University
February 8, 2014
February 25, 2014
February 25, 2014
December 2011
December 2012   (Final data collection date for primary outcome measure)
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).

Same as current
No Changes Posted
  • 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).

  • 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).
  • 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).

  • 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.
  • Adverse reaction [ Time Frame: 30 days after study drug administration ]
    Any adverse reaction related to study drug.
Same as current
Not Provided
Not Provided
 
Prasugrel With Lower Dose - Loading Dose
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Clopidogrel 600 mg
    Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel
    Other Name: Plavix 600 mg
  • Drug: Prasugrel 30 mg
    Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.
    Other Name: Effient 30 mg
  • Drug: Prasugrel 60 mg
    Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.
    Other Name: Effient 60 mg
  • Active Comparator: Clopidogrel 600 mg
    Patients administer conventional loading dose of clopidogrel 600 mg as active comparators.
    Intervention: Drug: Clopidogrel 600 mg
  • Experimental: Prasugrel 30 mg
    Patients administer lower loading dose of prasugrel 30 mg.
    Intervention: Drug: Prasugrel 30 mg
  • Active Comparator: Prasugrel 60 mg
    Patients administer conventional loading dose of prasugrel 60 mg as active comparators.
    Intervention: Drug: Prasugrel 60 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
January 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT02070159
PRELOAD-LD
Yes
Not Provided
Not Provided
Moo Hyun Kim, Dong-A University
Dong-A University
Not Provided
Not Provided
Dong-A University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP