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

Dong-A University

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Prasugrel 30 mg; Drug: Clopidogrel 600 mg; Drug: Prasugrel 60 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02070159

PRELOAD-LD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

Clopidogrel 600 mg

Active Comparator group

Description:

Patients administer conventional loading dose of clopidogrel 600 mg as active comparators.

Treatment:

Drug: Clopidogrel 600 mg

Prasugrel 30 mg

Experimental group

Description:

Patients administer lower loading dose of prasugrel 30 mg.

Treatment:

Drug: Prasugrel 30 mg

Prasugrel 60 mg

Active Comparator group

Description:

Patients administer conventional loading dose of prasugrel 60 mg as active comparators.

Treatment:

Drug: Prasugrel 60 mg