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

NCT05247931 | Unknown

• 1 other identifier: FADOI.01.2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 16

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.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

CASE

patients experiencing a recurrent stroke while on ASA therapy

Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

CONTROL

ASA-naïve patients experiencing a first atherothrombotic stroke

Diagnostic Test: TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine

Interventions

TXB2 assay of serum , and 11-dehydro-TXB2 assay of urine DIAGNOSTIC_TEST

Blood samples are analyzed for the assay of serum TXB2, and urine samples for the assay of 11-dehydro-TXB2

CASE; CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years
• Swallow-test positive
• Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group)
• Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group)
• Informed Consent

You may not qualify if:

• Transient ischemic attack (TIA)
• Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization)
• Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses
• Current treatment with other antiplatelet agents
• Thrombolysis and thrombectomy
• Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione n. 2 del 26/09/2019
• Carotid stenosis \>70%, with indication for revascularization
• Current treatment with ASA (only for patients in the CONTROL group)
• 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
• Thrombocytopenia (\<150000 platelets/μl)
• Renal failure (eGFR \<30 ml/min)
• Active cancer or disease in complete remission \<1 year, except squamous cell carcinoma and basal-cell carcinoma of the skin at initial stage
• Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy)
• Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>100 mmHg despite antihypertensive treatment)
• Chronic inflammatory bowel disease

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead

Study Sites (16)

Ospedale di Assisi

Assisi, Italy

RECRUITING

Ospedale Maggiore di Bologna

Bologna, Italy

ACTIVE NOT RECRUITING

Ospedale "S. Cuore di Gesù" Gallipoli

Gallipoli, Italy

NOT YET RECRUITING

Ospedale Vito Fazzi

Lecce, Italy

NOT YET RECRUITING

Ospedale Di Mantova

Mantova, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

NOT YET RECRUITING

P.O. Ostuni-Fasano - ASL BR

Ostuni, Italy

NOT YET RECRUITING

IRCCS Mondino

Pavia, Italy

RECRUITING

Azienda Ospedaliera Santa Maria della Misericordia

Perugia, Italy

RECRUITING

Ospedale di Pordenone

Pordenone, Italy

NOT YET RECRUITING

Policlinico Gemelli

Roma, Italy

RECRUITING

Ospedale Umberto I - ASP Siracusa

Syracuse, Italy

RECRUITING

Ospedale Molinette

Torino, Italy

RECRUITING

Ospedale Ca' Foncello di Treviso

Treviso, Italy

NOT YET RECRUITING

Ospedale di Circolo -ASST Settelaghi

Varese, Italy

NOT YET RECRUITING

Ospedale Dei Colli

Viterbo, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ANDREA FONTANELLA

  FONDAZIONE FADOI

  STUDY DIRECTOR

Central Study Contacts

ELISA ZAGARRI', MD

CONTACT

3387063726; elisa.zagarri@fadoi.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 21, 2022
• Study Start: November 7, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

IT (16)