N/A
N=246
Platelet Activity in Vascular Surgery and Cardiovascular Events
Cardiovascular Disease · Peripheral Artery Disease · Critical Limb Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT02106429 ↗Enrolled (actual)
246
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Patients in Which Platelet Activity Measurements Were Associated With Short-term Cardiovascular Events — 31; 16 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Which Platelet Activity Measurements Were Associated With Short-term Cardiovascular Events |
31; 16 | — |
Summary
Pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring platelet activity, thrombin generation, and markers of coagulation have been proposed to identify individuals at high-risk for cardiovascular events, however, it remains a research tool not ready for implementation in standard care.
The proposed study will add to the growing understanding of platelet activity and markers of coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in subjects undergoing vascular surgery; and will provide important data on the mechanism of increased platelet activity using micro RNA, RNA and DNA expression profiling. The study design is prospective and the main outcome measure is platelet activity measurements associated with short-term cardiovascular events in PAD patients
Eligibility Criteria
Inclusion Criteria
- Subjects undergoing non emergent lower extremity revascularization
- Use of aspirin within 48 hours prior to surgery
- Age > 21 years of age
- Able and willing to provide written informed consent for the study
Exclusion Criteria
- Use of any therapeutic anticoagulant
- Use of any nonsteroidal antiinflammatory drug (ibuprofen, naproxen, etc.) within 72 hours
- Thrombocytopenia (platelet count 500)
- Anemia (hemoglobin<9)
- Any known hemorrhagic diathesis
Data sourced from ClinicalTrials.gov (NCT02106429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.