Measurement of Platelet Dense Granule Release in Healthy Volunteers

Status Withdrawn

Clinical Trial Summary

Aspirin has been shown to reduce cardiovascular events in at risk individuals. Elucidation of mechanisms of aspirin resistance and a possible loss of effect of aspirin over time with chronic aspirin treatment necessitate a more precise method of measuring the "release phase" of platelet activation, including the release of dense granules from platelets.

Clinical Trial Description

This is a proposal for a pilot study to evaluate the feasibility of measuring 5-hydroxytryptamine (5-HT) release from platelets as an indicator of dense granule release during platelet activation in volunteers taking aspirin.

One phase of platelet response to activating agonists involves release of dense granules, which are known to contain 5HT (serotonin) and ATP. There are various methods of measuring the degranulation of platelets: ATP release can be measured using a lumiaggregometer, and release of 14C radiolabeled 5-HT from platelets. Using the aggregometer and a 14C labeled 5-HT assay can be used to measure 5-HT release from platelets.

Our experience suggests that ADP-induced ATP release is insensitive to detect very low levels of platelet dense granule release, which occurs in aspirin-treated subjects. The pilot study will permit optimizing the method for reliably detecting low levels of 5HT release in patients who achieve submaximal inhibition of the cyclooxygenase during aspirin treatment. ;

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Platelet Aggregation

Clinical Trial Details

NCT number	NCT00942617
Study type	Interventional
Source	Vanderbilt University
Contact
Status	Withdrawn
Phase	N/A
Start date	July 2009
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04492423` - VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
Completed	`NCT03355625` - Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
Completed	`NCT02958657` - Effect of Exercise on Platelet Reactivity After Myocardial Infarction	N/A
Completed	`NCT01815008` - Pharmacogenomics of Antiplatelet Response - I	Phase 4
Completed	`NCT03039205` - Platelet Aggregation in Patients With Coronary Artery Disease and Kidney Dysfunction Taking Clopidogrel or Ticagrelor	Phase 2
Completed	`NCT01557335` - A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540	Phase 1
Completed	`NCT05581238` - Validation of a Red Blood Cell Transfusion Prediction Model in a Low Transfusion Rate Population.
Completed	`NCT00233428` - Study to Determine Racial and Gender Differences in Platelet Aggregation	Phase 1
Completed	`NCT02112539` - Aggreguide A-100 ADP Assay Evaluation	N/A
Completed	`NCT00923988` - Effect of Passive Smoking on Platelet Function and Endothelial Function	N/A
Terminated	`NCT00748371` - Loss of Effect of Aspirin on Platelet Aggregation During Chronic Administration	Phase 4
Recruiting	`NCT05702463` - Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II	Phase 1
Recruiting	`NCT04842760` - PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Recruiting	`NCT06236243` - Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults	N/A
Completed	`NCT00763997` - Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages	N/A
Active, not recruiting	`NCT03615846` - Comparison of the VerifyNow® Aspirin Test and PRUTest® Platelet Reactivity Tests With Investigational Reagent to Reagents Registered in Japan
Completed	`NCT04369534` - Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction	Phase 4
Completed	`NCT01603966` - Low Dose Aspirin Studied With the AggreGuide	N/A
Completed	`NCT01152229` - Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine	N/A
Recruiting	`NCT03528603` - Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal	N/A