Clinical trial NCT01104441: Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspirin Resistance
Keywords: critical limb ischaemia
Aspirin resistance
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized for critical limb ischaemia and aspirin resistant using the VerifyNow®.

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.


Eligibility 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.

Primary outcomes:
measure: major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations.
timeFrame: 2 years
Secondary outcomes:
measure: major amputations, death
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: UH Bordeaux
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
References: