NCT00793754

Brief Summary

Despite formal recommendations, evidence of efficacy of aspirin in individuals with diabetes is scant and controversial. While the efficacy of aspirin versus placebo in patients with diabetes is currently under investigation in big randomized controlled trials, the putative additive effects of aspirin and statins in this population remain to be investigated. Moreover there are no data examining the pathophysiologic means by which aspirin with or without statins affects thrombosis in diabetic patients. The aim of this trial is to evaluate the efficacy of low-dose aspirin (100 mg/daily), statins, both or neither for the reduction of thrombin generation. These preventive strategies will be evaluated on the top of the other strategies aimed at optimizing the care of diabetic patients in terms of metabolic control and control of the other cardiovascular risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

2.6 years

First QC Date

November 18, 2008

Last Update Submit

October 25, 2011

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Thrombin generation

    8 weeks

Secondary Outcomes (1)

  • C-reactive protein

    8 weeks

Study Arms (4)

1

NO INTERVENTION

2

EXPERIMENTAL

Aspirin 100 mg / day

Drug: Aspirin

3

EXPERIMENTAL

Atorvastatin 40 mg / day

Drug: Atorvastatin

4

EXPERIMENTAL

Aspirin 100 mg / day + Atorvastatin 40 mg / day

Drug: Aspirin + Atorvastatin

Interventions

AspirinDRUG

100 mg / day for 8 weeks

2
AtorvastatinDRUG

40 mg / day for 8 weeks

3
Aspirin + AtorvastatinDRUG

Aspirin 100 mg / day + Atorvastatin 40 mg / day for 8 weeks

4

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus treated with insulin or orl agents
  • At least 50 years old

You may not qualify if:

  • Previous cardiovascular events
  • current or past (within last 30 days) treatment with aspirin
  • current or past (within last 180 days) treatment with statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)

Buenos Aires, Argentina

Location

Related Publications (1)

  • Macchia A, Laffaye N, Comignani PD, Cornejo Pucci E, Igarzabal C, Scazziota AS, Herrera L, Mariani JA, Bragagnolo JC, Catalano H, Tognoni G, Nicolucci A. Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial. PLoS One. 2012;7(3):e32894. doi: 10.1371/journal.pone.0032894. Epub 2012 Mar 28.

    PMID: 22470429DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

AspirinAtorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Alejandro Macchia, MD

    Fundacion GESICA

    PRINCIPAL INVESTIGATOR

  • Hernan Doval, MD

    Fundacion GESICA

    PRINCIPAL INVESTIGATOR

  • Juan J Fuselli, MD

    Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

    PRINCIPAL INVESTIGATOR

  • Pablo D Comignani, MD

    Hospital Aleman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 19, 2008

Study Start

March 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

AR(1)