Clinical trial NCT02070159: Prasugrel With Lower Dose - Loading Dose
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
prasugrel
platelet function tests
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Platelet reactivity
timeFrame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
Secondary outcomes:
measure: Percent inhibition
timeFrame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
measure: HPR
timeFrame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
measure: LPR
timeFrame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
measure: Bleeding event
timeFrame: 30 days after study drug administration
measure: Adverse reaction
timeFrame: 30 days after study drug administration
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: DongA University Hospital
Study officials:
References:
citation: 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. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.