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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00793754
Date of registration:	18/11/2008
Prospective Registration:	Yes
Primary sponsor:	Fundacion GESICA
Public title:	Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People RATIONAL
Scientific title:	Aspirin Statins Or Both For The Reduction Of Thrombin Generation In Diabetic People
Date of first enrolment:	March 2009
Target sample size:	30
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00793754
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Phase:	Phase 4

Countries of recruitment
Argentina

Contacts

Name:	Juan J Fuselli, MD
Address:
Telephone:
Email:
Affiliation:	Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Name:	Pablo D Comignani, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Aleman

Name:	Alejandro Macchia, MD
Address:
Telephone:
Email:
Affiliation:	Fundacion GESICA

Name:	Hernan Doval, MD
Address:
Telephone:
Email:
Affiliation:	Fundacion GESICA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diabetes mellitus treated with insulin or orl agents

- At least 50 years old

Exclusion Criteria:

- Previous cardiovascular events

- current or past (within last 30 days) treatment with aspirin

- current or past (within last 180 days) treatment with statins

Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Drug: Aspirin

Drug: Atorvastatin

Drug: Aspirin + Atorvastatin

Primary Outcome(s)

Thrombin generation [Time Frame: 8 weeks]

Secondary Outcome(s)

C-reactive protein [Time Frame: 8 weeks]

Secondary ID(s)

002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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