Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study

Study Overview
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Brief Summary
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Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with ASA, who are hospitalized in Internal Medicine departments for a recurrent atherothrombotic stroke.

Official Title
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Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study

Conditions
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Cerebrovascular Disease

Intervention / Treatment
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* Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Swallow-test positive Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group) Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group) Informed Consent Exclusion Criteria: Transient ischemic attack (TIA) Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization) Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses Current treatment with other antiplatelet agents Thrombolysis and thrombectomy Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione n. 2 del 26/09/2019 Carotid stenosis >70%, with indication for revascularization Current treatment with ASA (only for patients in the CONTROL group) Acute hepatitis, chronic active hepatitis, liver cirrhosis - or alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher than the upper limit of the normal range Thrombocytopenia (<150000 platelets/μl) Renal failure (eGFR <30 ml/min) Active cancer or disease in complete remission <1 year, except squamous cell carcinoma and basal-cell carcinoma of the skin at initial stage Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy) Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg despite antihypertensive treatment) Chronic inflammatory bowel disease Chronic treatment with corticosteroid drugs (for example Prednisone >5 mg/die or equivalent) Pregnancy (in case of child-bearing potential inclusion will be possible in case of negative pregnancy test)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CASE<br>patients experiencing a recurrent stroke while on ASA therapy | Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine<br>* Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2<br>|
| CONTROL<br>ASA-naïve patients experiencing a first atherothrombotic stroke | Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine<br>* Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group. | To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group. | day 8±1 |