Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia (Aspirine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01104441
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease. However, aspirin resistance has been described, mostly in cardiac patients and is an independent predictive factor for a poor survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among patients with peripheral arterial disease, those with critical limb ischemia have the worst cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied in these patients, and to our knowledge no study has been made to assess the prognosis value of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.

Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the bed-side point of care VerifyNow®, and will be followed during one year, including death, fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major amputation.


Condition or disease
Aspirin Resistance

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cardiovascular Events at One Year of Patients Hospitalized for Critical Limb Ischaemia and Aspirin Resistant Using the VerifyNow®. Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia
Actual Study Start Date : April 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. major amputations, death [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients hospitalized for critical limb ischaemia and aspirin resistant using the VerifyNow®.
Criteria

Inclusion Criteria:

  • any adult patient hospitalized for critical limb ischaemia and already treated by aspirin for at least 4 days before the VerifyNow® test. Critical limb ischemia is defined by the TASC II criteria : chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, confirmed by an ankle pressure subordinate or equal 50 mmHg and a toe pressure subordinate or equal 30 mmHg, or a transcutaneous oxygen tension subordinate or equal 30 mmHg

Exclusion Criteria:

  • non observance to aspirin treatment, other drugs that could interact with platelets (NSAIDs, other anti-platelet agents), other peripheral vascular disease status than critical limb ischemia, acute limb ischemia, platelet number lower than 100 000/mm3, hematocrit lower than 29%, known primary hemostasis disorder.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104441


Locations
Layout table for location information
France
UH Bordeaux
Bordeaux, France, 33 075
UH Toulouse
Toulouse, France, 31 059
Sponsors and Collaborators
University Hospital, Limoges
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01104441    
Other Study ID Numbers: I08022
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: May 2011
Keywords provided by University Hospital, Limoges:
critical limb ischaemia
Aspirin resistance
Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Pathologic Processes