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

• Sponsor: Fadoi Foundation, Italy (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05247931
• Collaborator: (none)
• Enrollment: 100
• Locations: 16
• Anticipated Duration (Months): 29.7
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disease	Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
• Actual Study Start Date: Nov 7, 2019
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
CASE patients experiencing a recurrent stroke while on ASA therapy	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
CONTROL ASA-naïve patients experiencing a first atherothrombotic stroke	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

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale di Assisi	Assisi		Italy
2	Ospedale Maggiore di Bologna	Bologna		Italy
3	Ospedale "S. Cuore di Gesù" Gallipoli	Gallipoli		Italy
4	Ospedale Vito Fazzi	Lecce		Italy
5	Ospedale Di Mantova	Mantova		Italy
6	ASST Grande Ospedale Metropolitano Niguarda	Milano		Italy
7	P.O. Ostuni-Fasano - ASL BR	Ostuni		Italy
8	IRCCS Mondino	Pavia		Italy
9	Azienda Ospedaliera Santa Maria della Misericordia	Perugia		Italy
10	Ospedale di Pordenone	Pordenone		Italy
11	Policlinico Gemelli	Roma		Italy
12	Ospedale Umberto I - ASP Siracusa	Siracusa		Italy
13	Ospedale Molinette	Torino		Italy
14	Ospedale Ca' Foncello di Treviso	Treviso		Italy
15	Ospedale di Circolo -ASST Settelaghi	Varese		Italy
16	Ospedale Dei Colli	Viterbo		Italy

Sponsors and Collaborators

• Fadoi Foundation, Italy

Investigators

• Study Director: ANDREA FONTANELLA, FONDAZIONE FADOI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fadoi Foundation, Italy
• ClinicalTrials.gov Identifier: NCT05247931
• Other Study ID Numbers: FADOI.01.2018
• First Posted: Feb 21, 2022
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebrovascular Disorders

Study Results

No Results Posted as of Feb 21, 2022