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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University Hospital, Limoges.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01104441
First received: April 13, 2010
Last updated: December 4, 2012
Last verified: April 2010

April 13, 2010
December 4, 2012
April 2010
April 2013   (final data collection date for primary outcome measure)
major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01104441 on ClinicalTrials.gov Archive Site
major amputations, death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
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Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia
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

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

patients hospitalized for critical limb ischaemia and aspirin resistant using the VerifyNow®.

Aspirin Resistance
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
153
April 2014
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Alexandre Le Guyader, Doctor (+33)(0)5 55 05 63 71 alexandre.le-guyader@unilim.fr
France
 
NCT01104441
I08022
No
University Hospital, Limoges
University Hospital, Limoges
Not Provided
Not Provided
University Hospital, Limoges
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP