The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry

Inclusion criteria

• Subject is ≥18 years of age
• Subject is willing to participate and provide informed consent
• Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator
• Groups A, B and C: BMI < 30 kg/m2; Groups D and E: BMI ≥ 35 kg/m2
• Subjects must be age ≥ 18 years old
• Serum Creatinine < 1.5 mg/dL
• Platelet count ≥ 150 K/uL
• Hematocrit ≥ 38%

Exclusion criteria

• Pregnant. If female of child-bearing age, negative urinary pregnancy test required at time of enrollment. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant she should inform her treating physician immediately.
• Established diagnosis of cirrhosis or active cancer
• History of allergy to aspirin or clopidogrel
• Any history of taking aspirin, antiplatelet drugs, NSAIDS, cyclooxygenase (COX)-2 inhibitors, warfarin, low-molecular weight heparin, thrombolytic agents, or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors) within 2 weeks prior to enrollment. (Refer to appendix)
• Use of certain antibiotics, cardiovascular drugs, lipid-lowering agents, antidepressants, antihistamines, non-prescription drugs, and supplements within the past 2 weeks. (Refer to appendix)
• Any major illness requiring hospitalization or surgery in the previous six months.
• Personal history of gastrointestinal bleed in the last 24 months or diagnosis of peptic ulcer disease in the last 12 months
• Lifetime personal history of hemorrhagic stroke.
• Personal or family history of bleeding diatheses, including hemophilias, von Willebrand's disease, Bernard-Soulier syndrome, or Glanzmann thrombasthenia (unless otherwise confirmed not present in study subject)