Aspirin Resistance Clinical Trial
— AspirineOfficial 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
NCT number | NCT01104441 |
Other study ID # | I08022 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2010 |
Est. completion date | April 2016 |
Verified date | May 2011 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | April 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | UH Bordeaux | Bordeaux | |
France | UH Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations. | 2 years | ||
Secondary | major amputations, death | 2 years |
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