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Antithrombotic properties of rafigrelide: a phase 1, open-label, non-randomised, single-sequence, crossover study
K Balasubramaniam, G Viswanathan, J Dragone
1Azfar G. Zaman, MD, FRCP, Consultant Cardiologist and Honorary Reader, Freeman Hospital and Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, NE7 7DN, United Kingdom, Tel.: +44 191 2137277, Fax: +44 191 2231417,
Thrombosis and Haemostasis
|February 21, 2014
Summary
Rafigrelide, a novel platelet-lowering agent, effectively reduced platelet counts and thrombus formation in healthy volunteers. This early study suggests rafigrelide possesses antithrombotic properties, even when combined with acetylsalicylic acid (ASA).
Area of Science:
- Pharmacology
- Hematology
- Cardiovascular Research
Background:
- Platelets are critical in atherothrombotic events.
- Understanding novel platelet-lowering agents is crucial for managing thrombotic diseases.
Purpose of the Study:
- To investigate the effects of rafigrelide, a novel platelet-lowering agent, on thrombus formation and characteristics.
- To assess the impact of rafigrelide alone and in combination with acetylsalicylic acid (ASA) on hemostatic parameters.
Main Methods:
- Phase 1, open-label, single-sequence, crossover study in healthy male volunteers.
- Ex vivo assessment of thrombus formation using the Badimon perfusion chamber under high and low shear conditions.
- Thrombus characteristics evaluated using thromboelastography.
Main Results:
- Rafigrelide significantly reduced platelet count and thrombus area under both high and low shear conditions.
- Reductions in thrombus area correlated with decreased platelet counts (r²=0.11, p=0.022).
- Rafigrelide prolonged clot formation time and reduced clot strength; addition of ASA showed no further effect.
Conclusions:
- Rafigrelide demonstrates significant platelet-lowering efficacy.
- The agent exhibits antithrombotic properties, reducing thrombus formation under varying shear conditions.
- Early phase data suggest rafigrelide's potential in managing atherothrombotic events.
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