CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Aspirindrug
Likely dose
Aspirin 81mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01201785
NCT01201785Phase 4Completed

Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease

University of Florida·interventional·Posted Sep 15, 2010·Updated Mar 6, 2012

In Brief

A Phase 4 clinical trial evaluating Aspirin for Type 2 Diabetes Mellitus and Coronary Artery Disease. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable COX-1 blockade of newly generated platelets. However, how different dosing regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate how increasing the frequency of aspirin administration, remaining within the daily recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with coronary artery disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2010
Enrollment StartJan 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.8 years ago

Interventions

Aspirindrug

After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.