Cerebrovascular Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTTXB2 assay of serum , and 11-dehydro-TXB2 assay of urine
Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2
Sponsors
Fadoi Foundation, Italy
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Swallow-test positive 3. Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group) 4. Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group) 5. Informed Consent
Exclusion criteria
1. Transient ischemic attack (TIA) 2. Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization) 3. Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses 4. Current treatment with other antiplatelet agents 5. Thrombolysis and thrombectomy 6. Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione n. 2 del 26/09/2019 7. Carotid stenosis \>70%, with indication for revascularization 8. Current treatment with ASA (only for patients in the CONTROL group) 9. 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 10. Thrombocytopenia (\<150000 platelets/μl) 11. Renal failure (eGFR \<30 ml/min) 12. Active cancer or disease in complete remission \<1 year, except squamous cell carcinoma and basal-cell carcinoma of the skin at initial stage 13. Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy) 14. Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>100 mmHg despite antihypertensive treatment) 15. Chronic inflammatory bowel disease 16. Chronic treatment with corticosteroid drugs (for example Prednisone \>5 mg/die or equivalent) 17. Pregnancy (in case of child-bearing potential inclusion will be possible in case of negative pregnancy test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Italy
Contacts
Primary ContactELISA ZAGARRI', MD
Outcome results
None listed