Effects of Aspirin Treatment on Fibrin Network Formation in Patients With Type 1 Diabetes

NCT01397513 | Completed Phase 4 DMC

• 2 other identifiers: 151:2005/763162005/1403-31/2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Fibrin network structure; Aspirin treatment; Platelet microparticles

Outcome Measures

Primary Outcomes (1)

• Fibrin network permeability

  Changes in fibrin network permeability after 4 weeks of treatment with either aspirin 75 or 320mg.

  At the start and end of each 4-week treatment period

Secondary Outcomes (2)

• Fibrin network permeability

  At the start and end of each 4-week treatment period

• Platelet microparticles

  At the start and end of each 4-week treatment period

Study Arms (2)

Aspirin 75mg

ACTIVE COMPARATOR

Drug: Aspirin

Aspirin 320mg

ACTIVE COMPARATOR

Drug: Aspirin

Interventions

Aspirin DRUG

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

Also known as: Trombyl

Aspirin 320mg; Aspirin 75mg

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus, type 1
• Levels of HbA1C (glycated hemoglobin) \<7.4% (NGSP standard)
• Levels of HbA1C \>8.4% (NGSP standard)

You may not qualify if:

• Prior aspirin treatment
• Treatment with anticoagulant drugs
• Ongoing treatment with NSAIDs or other antiplatelet drugs
• A history of macrovascular disease

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, 18288, Sweden

Location

Related Publications (19)

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  PMID: 22148098 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gun Jörneskog, MD PhD

  Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 19, 2011
• Study Start: March 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 19, 2011

Record last verified: 2006-03

Locations

SE (1)