Prasugrel With Lower Dose - Loading Dose

Phase 3CompletedNCT02070159

Dong-A University43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Clopidogrel 600 mgDRUG

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

Prasugrel 30 mgDRUG

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

Prasugrel 60 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

DongA University Hospital

Busan, South Korea

Outcomes

Primary Outcomes

Platelet reactivity

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).

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

Secondary Outcomes

Percent inhibition

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).

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

HPR

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).

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

LPR

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).

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

Bleeding event

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

Data from ClinicalTrials.gov

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