Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia

Aspirin Resistance Clinical Trial

— Aspirine  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104441
• Other study ID #: I08022
• Status: Completed
• Start date: April 2010
• Est. completion date: April 2016

Study information

• Verified date: May 2011
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aspirin Resistance
• Ischemia

Locations

Country	Name	City	State
France	UH Bordeaux	Bordeaux
France	UH Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

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