Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia (Aspirine)
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|ClinicalTrials.gov Identifier: NCT01104441|
Recruitment Status : Unknown
Verified April 2010 by University Hospital, Limoges.
Recruitment status was: Recruiting
First Posted : April 15, 2010
Last Update Posted : December 5, 2012
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||Phase|
|Aspirin Resistance||Phase 4|
|Study Type :||Observational|
|Estimated Enrollment :||153 participants|
|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 Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2014|
- major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations. [ Time Frame: 2 years ]
- major amputations, death [ Time Frame: 2 years ]
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
|Contact: Alexandre Le Guyader, Doctor||(+33)(0)5 55 05 63 firstname.lastname@example.org|
|Bordeaux, France, 33 075|
|Contact: Joël Constans, Professor (+33)(0)5 56 79 58 16 email@example.com|
|Toulouse, France, 31 059|
|Contact: Alessandra Bura-Riviere, Professor (+33)(0)5 61 32 24 38 firstname.lastname@example.org|