Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia (Aspirine)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2010 by University Hospital, Limoges.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT01104441

First received: April 13, 2010

Last updated: December 4, 2012

Last verified: April 2010

History of Changes

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.

Condition	Phase
Aspirin Resistance	Phase 4


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

Resource links provided by NLM:

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

major adverse cardiac events (MACE) including death, acute coronary syndromes, cardiac decompensation, stroke, major amputations. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104441

Contacts


Contact: Alexandre Le Guyader, Doctor	(+33)(0)5 55 05 63 71	alexandre.le-guyader@unilim.fr

Locations


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

Sponsors and Collaborators

University Hospital, Limoges

More Information


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	Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics

ClinicalTrials.gov processed this record on September 29, 2016

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