Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia (Aspirine)
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Purpose
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.
| Study Type: | Observational |
| Study Design: | 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 |
- major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- major amputations, death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 153 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients hospitalized for critical limb ischaemia and aspirin resistant using the VerifyNow®.
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| Contact: Alexandre Le Guyader, Doctor | (+33)(0)5 55 05 63 71 | alexandre.le-guyader@unilim.fr |
| France | |
| UH Bordeaux | Recruiting |
| Bordeaux, France, 33 075 | |
| Contact: Joël Constans, Professor (+33)(0)5 56 79 58 16 joel.constans@chu-bordeaux.fr | |
| UH Toulouse | Recruiting |
| Toulouse, France, 31 059 | |
| Contact: Alessandra Bura-Riviere, Professor (+33)(0)5 61 32 24 38 bura-riviere.a@chu-toulouse.fr | |
More Information
No publications provided
| Responsible Party: | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT01104441 History of Changes |
| Other Study ID Numbers: | I08022 |
| Study First Received: | April 13, 2010 |
| Last Updated: | December 4, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Limoges:
|
critical limb ischaemia Aspirin resistance |
Additional relevant MeSH terms:
|
Ischemia Pathologic Processes Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013