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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05247931
Other study ID # FADOI.01.2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 7, 2019
Est. completion date April 30, 2022

Study information

Verified date February 2022
Source Fadoi Foundation, Italy
Contact ELISA ZAGARRI', MD
Phone 3387063726
Email elisa.zagarri@fadoi.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
TXB2 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

Locations

Country Name City State
Italy Ospedale di Assisi Assisi
Italy Ospedale Maggiore di Bologna Bologna
Italy Ospedale "S. Cuore di Gesù" Gallipoli Gallipoli
Italy Ospedale Vito Fazzi Lecce
Italy Ospedale Di Mantova Mantova
Italy ASST Grande Ospedale Metropolitano Niguarda Milano
Italy P.O. Ostuni-Fasano - ASL BR Ostuni
Italy IRCCS Mondino Pavia
Italy Azienda Ospedaliera Santa Maria della Misericordia Perugia
Italy Ospedale di Pordenone Pordenone
Italy Policlinico Gemelli Roma
Italy Ospedale Umberto I - ASP Siracusa Siracusa
Italy Ospedale Molinette Torino
Italy Ospedale Ca' Foncello di Treviso Treviso
Italy Ospedale di Circolo -ASST Settelaghi Varese
Italy Ospedale Dei Colli Viterbo

Sponsors (1)

Lead Sponsor Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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