Clinical trial NCT05247931: Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
Official title: Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Disease
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with athero-thrombotic stroke, to be divided into CASE group (50 patients experiencing a recurrent stroke while on ASA therapy) and CONTROL group (50 ASA-naïve patients experiencing a first atherothrombotic stroke), with ratio 1:1.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: day 8±1
Secondary outcomes:
Other outcomes:
Locations:
city: Assisi
country: Italy
facility: Ospedale di Assisi
city: Bologna
country: Italy
facility: Ospedale Maggiore di Bologna
city: Gallipoli
country: Italy
facility: Ospedale "S. Cuore di Gesù" Gallipoli
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Mantova
country: Italy
facility: Ospedale Di Mantova
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Ostuni
country: Italy
facility: P.O. Ostuni-Fasano - ASL BR
city: Pavia
country: Italy
facility: IRCCS Mondino
city: Perugia
country: Italy
facility: Azienda Ospedaliera Santa Maria della Misericordia
city: Pordenone
country: Italy
facility: Ospedale di Pordenone
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Siracusa
country: Italy
facility: Ospedale Umberto I - ASP Siracusa
city: Torino
country: Italy
facility: Ospedale Molinette
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello di Treviso
city: Varese
country: Italy
facility: Ospedale di Circolo -ASST Settelaghi
city: Viterbo
country: Italy
facility: Ospedale Dei Colli
Study officials:
affiliation: FONDAZIONE FADOI
name: ANDREA FONTANELLA
role: STUDY_DIRECTOR
References: