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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Diagnostic test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: ELISA ZAGARRI', MD; Phone Number: +39 3387063726; Email: elisa.zagarri@fadoi.org

Study Locations

• Italy
  • Assisi, Italy
    • Recruiting
    • Ospedale Di Assisi
    • Contact: MANUEL MONTI
    • Principal Investigator: MANUEL MONTI
  • Bologna, Italy
    • Active, not recruiting
    • Ospedale Maggiore di Bologna
  • Gallipoli, Italy
    • Not yet recruiting
    • Ospedale "S. Cuore di Gesù" Gallipoli
    • Contact: MARINA SPAGNOLO
    • Principal Investigator: LUIGI RIA
  • Lecce, Italy
    • Not yet recruiting
    • Ospedale Vito Fazzi
    • Contact: LEONARDO BARBARINI
    • Principal Investigator: LEONARDO BARBARINI
  • Mantova, Italy
    • Not yet recruiting
    • Ospedale di Mantova
    • Contact: MAURO PAGANI
    • Principal Investigator: MAURO PAGANI
  • Milano, Italy
    • Not yet recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
    • Contact: ARIANNA PANI
    • Principal Investigator: FABRIZIO COLOMBO
  • Ostuni, Italy
    • Not yet recruiting
    • P.O. Ostuni-Fasano - ASL BR
    • Contact: PIETRO GATTI
    • Principal Investigator: PIETRO GATTI
  • Pavia, Italy
    • Recruiting
    • IRCCS Mondino
    • Contact: FEDERICA FERRARI
    • Principal Investigator: ANNAMARIA CAVALLINI
  • Perugia, Italy
    • Recruiting
    • Azienda Ospedaliera Santa Maria della Misericordia
    • Contact: MARA GRAZIANI
    • Principal Investigator: MARIAGIULIA MOSCONI
  • Pordenone, Italy
    • Not yet recruiting
    • Ospedale di Pordenone
    • Contact: ALESSANDRO GREMBIALE
    • Principal Investigator: MAURIZIO TONIZZO
  • Roma, Italy
    • Recruiting
    • Policlinico Gemelli
    • Contact: IRENE SALA
    • Principal Investigator: GIOVANNI FRISULLO
  • Siracusa, Italy
    • Recruiting
    • Ospedale Umberto I - ASP Siracusa
    • Contact: ENZO SANZARO
    • Principal Investigator: ENZO SANZARO
  • Torino, Italy
    • Recruiting
    • Ospedale Molinette
    • Contact: CRISTINA ZOCCHI
    • Principal Investigator: CRISTINA ZOCCHI
  • Treviso, Italy
    • Not yet recruiting
    • Ospedale Ca' Foncello di Treviso
    • Contact: ROBERTA BUSO
  • Varese, Italy
    • Not yet recruiting
    • Ospedale di Circolo -ASST Settelaghi
    • Contact: FEDERICO CARIMATI
    • Principal Investigator: MAURIZIO VERSINO
  • Viterbo, Italy
    • Not yet recruiting
    • Ospedale Dei Colli
    • Contact: MARISA DISTEFANO
    • Principal Investigator: MARISA DISTEFANO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Investigators: Study Director: ANDREA FONTANELLA, FONDAZIONE FADOI

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2019
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): April 30, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (ACTUAL): February 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: FADOI.01.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No