CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Aspirindrug
Likely dose
Aspirin 320mgfrom 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/NCT01397513
NCT01397513Phase 4Completed

Effects of Low and High Doses of Aspirin Treatment on Fibrin Network Formation in Patients With Type 1 Diabetes and Possible Influence of the Glycemic Control.

Karolinska Institutet·interventional·Posted Jul 19, 2011·Updated Jul 19, 2011

In Brief

A Phase 4 clinical trial evaluating Aspirin for Diabetes Mellitus, Type 1. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The fibrin network is an important component of an arterial thrombus and its structure influences the degradation of the formed clot. A tighter and less permeable fibrin network, which is less susceptible to fibrinolysis, is formed in patients with manifest cardiovascular disease (CVD) or conditions associated with increased risk of atherothrombotic complications. In a previous study we have shown reduced fibrin network permeability in patients with type 1 diabetes, which may contribute to their increased risk of CVD. Low dose aspirin treatment is standard in management of CVD; however, the effect seems reduced in patients with diabetes. Our previous studies have shown that aspirin treatment alters the fibrin network in non-diabetic individuals and increases the fibrin network permeability. The effect of aspirin on fibrin network formation in patients with diabetes is unclear. We hypothesized that patients with type 1 diabetes might need higher doses of aspirin than the recommended low dose (75mg) treatment to gain effects on fibrin network permeability, and that the effects of aspirin treatment on fibrin network in these patients are influenced by the glycemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 19, 2011
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.0 years ago

Interventions

Aspirindrug

Tablets, 75 or 320mg once daily for 4 weeks. A 4-week wash-out period separated the two treatment periods.