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

Cerebrovascular Disease Clinical Trial

— ASTRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247931
• Other study ID #: FADOI.01.2018
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders

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