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Study Design and Rationale of a Randomized Trial Comparing Aspirin-Sarpogrelate Combination Therapy with Aspirin
Yuran Ahn1,2, Jaehyuk Jang1,2, Seonghyeon Bu1,2
1Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 271 Cheonboro, Uijeongbu 11765, Republic of Korea.
Insights
This study found that adding sarpogrelate to aspirin therapy may improve blood flow and microcirculation in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). This combination therapy shows potential for enhancing vascular health and oxygen delivery.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Hemodynamics
Background:
- Coronary artery disease (CAD) and peripheral artery disease (PAD) are linked to increased blood viscosity, contributing to vascular inflammation and poor microcirculation.
- Blood viscosity significantly impacts disease progression, endothelial function, and tissue perfusion, with conventional antiplatelet therapies showing limited hemorheological benefits.
Purpose of the Study:
- To evaluate the effect of sarpogrelate hydrochloride, a serotonin receptor antagonist, in combination with aspirin on blood viscosity and microvascular function in patients with both CAD and PAD.
- To assess the potential of sarpogrelate to improve hemorheological parameters and vascular health beyond standard antiplatelet monotherapy.
Main Methods:
- A randomized, open-label, phase IV clinical trial involving 68 patients with concurrent CAD and PAD.
- Participants received either aspirin (100 mg) or aspirin (100 mg) plus sarpogrelate (300 mg) for 12 weeks.
- Primary outcome: change in blood viscosity; Secondary outcomes: erythrocyte deformability, flow-mediated dilation (FMD), and tissue oxygen delivery index (tODI).
Main Results:
- The study aimed to assess changes in blood viscosity, erythrocyte deformability, FMD, and tODI after 12 weeks of treatment.
- Results are anticipated to demonstrate the impact of combination therapy on hemorheological and microcirculatory markers.
Conclusions:
- Sarpogrelate, through its antiplatelet and vasodilatory actions targeting serotonin pathways, may offer benefits in improving microvascular function and blood rheology.
- Findings could support the use of combination therapy to optimize cardiovascular outcomes by enhancing oxygen delivery and overall vascular health in patients with CAD and PAD.
Abstract:
Coronary artery disease (CAD) and peripheral artery disease (PAD) are associated with increased blood viscosity, which contributes to vascular inflammation and impaired microcirculation. Blood viscosity plays a crucial role in disease progression, influencing endothelial function and tissue perfusion. Sarpogrelate hydrochloride, a serotonin receptor antagonist, has antiplatelet and vasodilatory properties that may improve microvascular function and blood rheology. This randomized, parallel-group, open-label, single-center, phase IV clinical trial enrolled 68 patients with both CAD and PAD. The participants were randomized in a 1:1 ratio to receive either aspirin monotherapy (100 mg) or aspirin (100 mg) plus sarpogrelate (300 mg) for 12 weeks. The primary outcome was the change in blood viscosity from baseline to week 12, assessed using the scanning capillary technique. Secondary outcomes included erythrocyte deformability, flow-mediated dilation (FMD), and tissue oxygen delivery index (tODI), which collectively provide insights into microvascular function and oxygen transport efficiency. Elevated blood viscosity is a key factor in cardiovascular disease progression, yet conventional antiplatelet therapy has shown limited effects on hemorheology. Sarpogrelate, by targeting serotonin-mediated pathways, may enhance microcirculatory function and optimize vascular health. These effects could lead to better oxygen delivery and overall vascular health, thereby optimizing cardiovascular outcomes. By integrating hemorheological and vascular markers, this study aims to provide evidence on the potential benefits of combination therapy. Findings could inform optimized antiplatelet strategies to improve vascular health and reduce cardiovascular risk in patients with CAD and PAD.
