Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia

NCT01104441 | Completed

• 1 other identifier: I08022
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Aspirin Resistance

Keywords

critical limb ischaemia; Aspirin resistance

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations.

  2 years

Secondary Outcomes (1)

• major amputations, death

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients hospitalized for critical limb ischaemia and aspirin resistant using the VerifyNow®.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

UH Bordeaux

Bordeaux, 33 075, France

Location

UH Toulouse

Toulouse, 31 059, France

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 14, 2019

Record last verified: 2011-05

Locations

FR (2)