Aspirin Dosing in Diabetic Patients

NCT01201785 | Completed Phase 4 Results DMC

• 1 other identifier: UFJ 2008-88
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Coronary Artery Disease

Keywords

diabetes mellitus, coronary artery disease, aspirin therapy

Outcome Measures

Primary Outcomes (1)

• Collagen Induced Aggregation

  Collagen induced aggregation using light transmittance aggregometry

  after 1 -week of treatment

Study Arms (1)

Aspirin dose range

EXPERIMENTAL

Drug: Aspirin

Interventions

Aspirin DRUG

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.

Aspirin dose range

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes mellitus patients between 18 to 75 years with stable coronary artery disease

You may not qualify if:

• Blood dyscrasia or bleeding diathesis
• Oral anticoagulation therapy with a coumadin derivative
• Recent antiplatelet treatment (\< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole Platelet count \< 100 /microL
• History of gastrointestinal bleed within last 6 months
• History of cerebrovascular accident within last 3 months
• History of hospitalization for an acute coronary event or coronary revascularization (percutaneous or surgical) in the past 12 months
• Active bleeding or hemodynamic instability
• Any active malignancy
• Serum creatinine \> 2 mg/dL
• Baseline ALT \> 2.5 times the upper limit of normal
• Pregnant females
• HbA1C \> 10%
• Use of nonsteroidal anti-inflammatory drugs past 10 days.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• Capodanno D, Patel A, Dharmashankar K, Ferreiro JL, Ueno M, Kodali M, Tomasello SD, Capranzano P, Seecheran N, Darlington A, Tello-Montoliu A, Desai B, Bass TA, Angiolillo DJ. Pharmacodynamic effects of different aspirin dosing regimens in type 2 diabetes mellitus patients with coronary artery disease. Circ Cardiovasc Interv. 2011 Apr 1;4(2):180-7. doi: 10.1161/CIRCINTERVENTIONS.110.960187. Epub 2011 Mar 8.

  PMID: 21386092 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Diabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dominick J. Angiolillo, MD, PhD
• Organization: University of Florida-Jacksonville

dominick.angiolillo@jax.ufl.edu

904-244-3933

Study Officials

• Dominick J Angiolillo, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 15, 2010
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 6, 2012
• Results First Posted: March 6, 2012

Record last verified: 2012-03

Locations

US (1)